Delivery Method:Via Email Return Receipt RequestedReference #:320-26-104Product:DrugsOver-the-Counter DrugsRecipient:Mr. Peter J. VlcekCEOIsland Kinetics, Inc. d.b.a. CoValence Laboratories460 S. Benson Ln. Suite 1-3Chandler, AZ 85224-5663United StatesPete@CoValence.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-104July 16, 2026Dear Mr. Vlcek:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Island Kinetics, Inc. d.b.a. CoValence Laboratories, FEI 3002408934, at 460 S. Benson Ln. Suite 1-3, Chandler, AZ, from January 14 to 23, 2026.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).In addition, violations were identified and documented during a review of your product labeling. Based on our review, your TreeActiv Cystic Acne Spot Treatment, Ayadara Warrior Two Acne Spot Treatment, and Skin Script Cranberry Turnover Peel drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a), 331(d). In addition, TreeActivCystic Acne Spot Treatment and Ayadara Warrior Two Acne Spot Treatment are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introducing or delivering these misbranded products for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.We reviewed your February 12, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Lack of Process ValidationYou lacked process validation data for all your over-the-counter (OTC) drug products to demonstrate that your manufacturing process is reproducible and controlled to consistently yield drug products of uniform character and quality. For example, the inspection documented that OTC Formula (b)(4), Finished Lots/Bulks (b)(4) and OTC Formula (b)(4), Finished Lots/Bulks (b)(4) were released without process validation.Our inspection also documented that your firm failed to perform process validation at the actual commercial manufacturing (b)(4) of (b)(4) for OTC Formula (b)(4). You routinely operated the (b)(4) at this (b)(4) which exceeded the qualified limit of (b)(4). Your director of quality confirmed that no process validation had been performed at the actual operating (b)(4) of (b)(4) for OTC Formula (b)(4).In your response, you indicate that since July 16, 2025, drug products manufactured and released were covered by a process validation protocol. You also commit to execute three qualification batches for OTC Formula (b)(4) by February 2026.Your response is inadequate because you did not address batches released prior to July 16, 2025 that may not be covered by a process validation protocol. Additionally, you did not provide your interim plan for drugs distributed before process validation activities are completed to ensure you produce drug products of acceptable quality.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.See FDA’s guidance for industry Process Validation: General Principles and Practices for general principles and approaches that the FDA considers appropriate elements of process validation at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-validation-general-principles-and-practices.Inadequate Equipment Cleaning ValidationYour firm did not have adequate cleaning validation studies for the equipment used to manufacture OTC drug products. For example, you lacked a documented rationale for the products selected for cleaning validation studies. Additionally, you lacked an analytical method to identify and measure specific drug residues to ensure that the cleaning process is effective in preventing cross-contamination between drug products manufactured on the same equipment.In your response, you opened a corrective action and preventive action (CAPA) plan for cleaning validation deficiencies. You also commit to engaging a consultant to review the existing cleaning validation package, produce a formal worst-case selection justification, and identify any additional analytical work required.Your response is inadequate because you did not include a risk assessment of previously distributed OTC drug products, a CAPA plan with clear timelines, and evidence that your current cleaning procedures are effective for any of the equipment used in OTC drug product manufacturing at your facility. Furthermore, your response lacks a plan to develop a residue-specific analytical method capable of confirming removal of worst-case drug residues.Inadequate (b)(4) System ValidationYour firm modified your (b)(4) system (number (b)(4)) in October 2024 by adding a production point of use in the (b)(4) area and replacing the (b)(4) tank with a (b)(4) tank without adequate requalification.Additionally, your contract testing laboratory reported multiple (b)(4) results exceeding United States Pharmacopeia (USP) specifications for (b)(4) samples from your (b)(4) system points of use which you failed to investigate or remediate.(b)(4) must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes. The lack of adequate (b)(4) system validation provides no assurance the system performs as intended. Your use of (b)(4) from an unvalidated system in pharmaceutical manufacturing can adversely affect drug product quality and patient safety.Biofilm formation is also a significant concern in (b)(4) systems operating at (b)(4) as biofilms can lead to undesirable levels of microorganisms and endotoxins. Your (b)(4) system material selection and operating (b)(4) may present challenges for maintaining adequate sanitization and microbiological control necessary to ensure that your (b)(4) meets established pharmaceutical specifications.In your response, you commit to engaging a consultant to evaluate whether revalidation of (b)(4) system (number (b)(4)) was required. You also commit to updating your change control form to require a risk assessment for future system changes. Additionally, you opened a CAPA for investigations, committed to revising the investigation form and providing training to staff.Your response is inadequate because you did not provide a detailed (b)(4) system validation plan and an interim plan to ensure that the (b)(4) is suitable for its intended use. You also did not adequately address the recurring (b)(4) contamination in your (b)(4) system. In addition, you did not provide documentation to support your proposed corrective actions. These concerns indicate that microbial contamination and organic impurities in your (b)(4) system were not adequately controlled.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle along with associated procedures. Describe your program for process performance qualification and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow up actions to be taken for the distributed drug products produced without performing any process validation studies.Process performance protocol(s), and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets (b)(4), USP monograph specifications and appropriate microbial limits.A comprehensive remediation plan for the design, control, and maintenance of the (b)(4) system, including:o a comprehensive evaluation of vulnerabilities of (b)(4)-system design and control and summarize all deficiencies found in the system. The summary should, at a minimum, describe various system characteristics that were assessed for adequacy (for example, system (b)(4), materials of construction, slope, identified dead-legs, stagnant locations, unsanitary fittings, flow velocity, maintenance requirements).o A CAPA plan that corrects all (b)(4)-system design and control deficiencies. Include your plans for new system installation, or extensive design remediation (for example, removal of all dead-legs); preparation of a system-validation protocol; and the planned timeline for completion of thorough (b)(4)-system validation studies.Your plans for improved (b)(4)-system monitoring, including but not limited to the routine microbial testing of (b)(4) and appropriate limits (objectionable microbes, total count alert/action limits) to ensure the (b)(4) acceptability for use in each batch of drug product produced by your firm. Ensure that your (b)(4) total-count limits are appropriately stringent, in view of the intended use of each of the products produced by your firm.A detailed risk assessment addressing the potential effects of the observed (b)(4)-system failures on the quality of all drug product batches currently in U.S. distribution. Specify the actions you will take in response to the risk assessment, such as customer notifications and product recalls.2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).Your firm failed to adequately investigate viscosity failures identified during stability testing of distributed OTC drug products. Specifically, stability testing records documented multiple viscosity out-of-specification (OOS) results without adequate root cause determination, CAPA, or documented justification for the established viscosity specifications.In your response, you attribute the root cause to lack of procedures for third-party OOS investigations and commit to creating a new SOP and provide staff training.Your response is inadequate because you did not include a risk assessment of previously distributed products with viscosity OOS results, a CAPA plan with clear timelines, documented justification for your established viscosity specifications, and an assessment of the link between your unvalidated processes, unqualified equipment, and the observed viscosity failures.It is essential to conduct thorough well documented, and scientifically sound investigations to identify root causes of OOS results, evaluate all potentially affected batches, and implement timely and effective CAPA plans.You are also responsible for ensuring your manufacturing process is reproducible and under control, and for determining any potential correlation between discrepancies and OOS results obtained with your critical manufacturing parameters.In response to this letter, provide:A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for US products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS:o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation and any manufacturing operation improvements.o Your retrospective review should include all test results received from your third-party laboratory.A comprehensive review and remediation plan for your OOS and out-of-limit (OOL) result investigation systems. The CAPA should include, but not be limited to, addressing the following:o Quality unit oversight of laboratory investigationso Identification of adverse laboratory control trendso Resolution of causes of laboratory variationo Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identifiedo Adequate scoping of each investigation and its CAPAo Revised OOS investigation procedures with these and other remediationsA detailed risk assessment addressing the hazards posed by distributing drug products with potentially objectionable contamination. Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.Complete investigations into all batches with microbial contamination whether or not later invalidated. The investigations should detail your findings regarding the root causes of the contamination.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.Unapproved New Drug ViolationsBased on a review of your product labeling, your TreeActiv Cystic Acne Spot Treatment, Ayadara Warrior Two Acne Spot Treatment, and Skin Script Cranberry Turnover Peel are drugs under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling that provide evidence of the intended uses (as defined in 21 CFR 201.128) of these products as a drug include, but may not be limited to, the following:TreeActiv Cystic Acne Spot Treatment“CYSTIC ACNE SPOT TREATMENT…DRUG FACTS…USE for the treatment of acne…is the most effective treatment for severe and cystic acne.” [from the product label]Ayadara Warrior Two Acne Spot Treatment“CYSTIC, HORMONAL, & SEVERE ACNE SPOT TREATMENT…DRUG FACTS…USE for the treatment of acne…treatment that minimizes pimples, zaps zits, and helps prevent future breakouts. [from the product label]Skin Script Cranberry Turnover Peel“Benefits: Contains 20% salicylic to dry oil and reduce bacterial attacks…Cranberry is an excellent antioxidant to reduce inflammation associated to acne.” [from the product label]TreeActiv Cystic Acne Spot Treatment, Ayadara Warrior Two Acne Spot Treatment, and Skin Script Cranberry Turnover Peel are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p) because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355 are in effect for these drug products identified above. Accordingly, these products are unapproved new drugs. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).We note that under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to nonprescription acne treatment drug products, such as your TreeActiv Cystic Acne Spot Treatment and Ayadara Warrior Two Acne Spot Treatment, in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph, here M006: Topical Acne Drug Products for Over-the-Counter Human Use (hereinafter “M006”).1 However, TreeActiv Cystic Acne Spot Treatment and Ayadara Warrior Two Acne Spot Treatment, and do not conform to the conditions specified in M006 for the reasons described below.Your TreeActiv Cystic Acne Spot Treatment product as labeled, includes indications that do not comply with the permitted indications for an acne treatment drug product. For example, claims such as “CYSTIC ACNE SPOT TREATMENT” and “most effective treatment for cystic and severe acne” go beyond merely describing the general intended uses for an acne treatment drug product and are not permitted under M006.Similarly, Ayadara Warrior Two Acne Spot Treatment, as labeled, includes indications that do not comply with the indications for an acne treatment drug product. For example, claims such as “CYSTIC, HORMONAL, & SEVERE ACNE SPOT TREATMENT” go beyond merely describing the general intended uses for an acne treatment drug product and are not permitted under M006.Thus, your TreeActiv Cystic Acne Spot Treatment and Ayadara Warrior Two Acne Spot Treatment products do not comply with the applicable conditions specified in M006 and have not and have not otherwise been found GRASE.2 Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without an approved application. Because there are no applications in effect for these products, these products are unapproved new drugs.Misbranded Drug ViolationsAdditionally, TreeActiv Cystic Acne Spot Treatment and Ayadara Warrior Two Acne Spot Treatment are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee) because these products are nonprescription drugs, subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).Repeat Violations at FacilityIn previous inspections, conducted in 2016 and 2020, FDA cited similar CGMP violations. You proposed specific remediation for these violations in your responses. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.CGMP Consultant RecommendedBecause you failed to correct repeat violations, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Cosmetics Manufactured for Distribution in the United StatesIn addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3002408934 and ATTN: Chhaya Shetty.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research____________________1 M006 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000013, available at FDA’s website OTC Monographs @ FDA [https://dps.fda.gov/omuf].2 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that TreeActiv Cystic Acne Spot Treatment and Ayadara Warrior Two Acne Spot Treatment products are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).

Delivery Method:VIA UPSReference #:320-26-103Product:DrugsOver-the-Counter DrugsRecipient:Mr. Vasanth SamagaFounder-DirectorBioMylz Pvt. Ltd.# cj-1, Santra Magan Place Apartment off Banneraghatta RoadDoddakammanahalli, near Maruthi Dental CollegeBangalore 560076IndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-103July 13, 2026Dear Mr. Samaga:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, BioMylz Pvt. Ltd., FEI 3013697420, at #21 - D #21 - D Building No 1, Bengaluru, Karnataka, India, from February 4 to 9, 2026.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).In addition, violations were identified and documented during a review of your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS). Based on our review, you failed to provide complete drug listing information for your Soraresal Cream, NDC 73526-002, and Equate Medicated Vaporizing Steam Liquid, NDC 73559-011, as required under section 510(j) of the FD&C Act, 21 U.S.C. 360(j). Failure to provide complete listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Furthermore, these drugs are misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o). Introducing or delivering these products for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.CGMP ViolationsWe reviewed your February 27, 2026, response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supporting documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).You manufacture an over-the counter (OTC) drug product, a topical psoriasis cream, for the U.S market.Your quality unit (QU) failed to ensure that all CGMP records were retained and available for review. Our investigators discovered a garbage bag containing original data. The recovered documents included, but were not limited to:executed production batch recordsmedia preparationincubation and sterilization cycle logbook pagesfinished product sample collection formsenvironmental monitoring sample formsproduct complaint and change control log formsAdditionally, your firm failed to maintain complete laboratory records, including original data for laboratory analyses conducted on commercial drug products. Specifically, you did not retain original data supporting laboratory test results used to release commercial batches, and you were not able to make this data available for FDA review.Furthermore, you did not adequately control laboratory logbooks. Your logbooks had unnumbered pages and lacked reconciliation, and you did not permanently and contemporaneously document original data. For example, your personnel used a pencil to initially record volume entries and subsequently overwrote them in ink after completion of the weight check activity.In your response, you attributed the torn documents to the actions of a former employee (ex-plant manager) who made false entries to intentionally increase yield. You also stated that this was an isolated and exceptional incident with no identified impact on approved or controlled documents and that the employee was terminated. However, your statement in the response is contradicted by the evidence provided to our investigators. This evidence indicates that the manager had been repeatedly observed on multiple occasions violating data integrity practices including, but not limited to, destruction of batch production records, destruction of laboratory-controlled records, and falsification of production and laboratory data.Your response is inadequate. You did not address your egregious and persistent data integrity issues, nor did you provide any detailed or systemic remediations. You also did not conduct a comprehensive evaluation of the manufacturing and laboratory records to determine the impact of the data integrity breeches on the quality of your OTC drug products manufactured for the U.S. market.All testing records and raw data must be handled appropriately and in accordance with established procedures. Your response fails to describe immediate corrective actions to prevent the alteration or destruction of CGMP data.Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents:• ICH Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download• Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download,Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.Reliability of data is compromised when there is a failure to maintain complete records of the conditions and data associated with all tests and manufacturing activities. The lack of complete data compromises the ability of the QU to exercise its function of ensuring compliance to applicable standards.We strongly recommend that you retain an independent qualified third-party consultant to assist in your remediation. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies and inconsistencies in data, records, and reporting. Your investigation should include:o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.o An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity deficiencies.o A comprehensive retrospective evaluation of the nature of the testing and manufacturing data integrity deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all occurrences.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a data integrity event and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action plan. Your strategy should include:o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all data, including analytical data, manufacturing records, and all data submitted to FDA.o A comprehensive description of the root causes of each data integrity deviation, including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for the data integrity breaches remain able to influence CGMP-related or drug application data at your firm.o Interim measures describing the actions you have taken or will take to ensure the quality of your drugs and protect patients, such as notifying your customers, recalling product(s), conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.o A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.o Inform FDA if you will be hiring a chief integrity officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by independent quality assurance function, along with expertise from outside entities whenever needed).o A status report for any of the above activities already underway or completed.2. Your firm failed to establish adequate written procedures for production and process control designed to assure that drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100(b)).You failed to demonstrate adequate validation of your manufacturing process. You were unable to demonstrate that your (b)(4) processes assure (b)(4) after commercial scale-up of your process. For example, critical control process parameters such as (b)(4) were not adequately documented in batch records. Furthermore, you did not conduct adequate in-process hold time studies and stability studies to support shelf life.You also failed to adequately demonstrate the effectiveness of your cleaning procedures to ensure the removal of active pharmaceutical ingredient (API) residue, as well as control of potential microbial contamination from your shared manufacturing equipment after the scale-up.Your response indicates that process and cleaning validation were performed in 2019 prior to the commercial scale-up, and you commit to performing process validation for the upcoming commercial orders. Additionally, you stated that cleaning validation studies, including residue limit calculations and worst-case assessments, have been conducted and documented. However, your response is inadequate. You lack supporting documentation for both activities, and you did not provide a timeline for completing the re-validation following commercial scale-up.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drug products.Also, process qualification studies characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established. They include intensive monitoring and testing throughout each significant process stage (e.g., (b)(4)batch formulation and filling).Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle. See FDA’s guidance for industry, Process Validation: General Principles and Practices, for general principles and approaches that the FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.A timeline for performing appropriate process performance qualification for each of your marketed drug products. Also provide a risk assessment and any follow-up actions to be taken for the distributed drug products produced prior to performing any process validation studies.Process performance protocols, and written procedures for qualification of equipment and facilities.Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:o drugs with higher toxicitieso drugs with higher drug potencieso drugs of lower solubility in their cleaning solventso drugs with characteristics that make their manufacturing equipment difficult to cleano swabbing locations for areas that are most difficult to cleano maximum hold times before cleaningA description of the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.3. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).You failed to ensure components and drug products are adequately monitored for microbiological contamination. For example, your topical psoriasis cream does not include testing for the presence of objectionable microorganisms, such as Staphylococcus aureus and Pseudomonas aeruginosa, critical for cutaneous products.In response to this letter, provide:A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, we strongly recommend that your firm engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Responsibilities as a ContractorDrugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.You and your customer Atrimed Pharmaceuticals Private Limited have a quality agreement regarding the manufacture of the U.S. marketed Soraresal Cream OTC drug product.You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.Drug Listing ViolationsSection 510(j) of the FD&C Act and 21 CFR Part 207 set forth the requirements for the listing of drugs. Under section 510(j)(1) of the FD&C Act and 21 CFR 207.49(a)(12), a registrant must provide the name and Unique Facility Identifier of every other establishment where manufacturing is performed for a drug and the type of operation performed at each such establishment. Under 21 CFR 207.1, “manufacture” includes manipulation, sampling, testing, or control procedures applied to the final product or to any part of the process, including, for example, analytical testing of drugs for another registered establishment’s drug. Upon review of your firm’s drug listings, it was found that you failed to include (b)(4) in your drug listing for Soraresal Cream, NDC 73526-002, and (b)(4) in your drug listing for Equate Medicated Vaporizing Steam Liquid, NDC 73559-011, as required by 21 CFR 207.49(a)(12). Failure to provide listing information for a drug in accordance with 510(j) of the FD&C Act is prohibited under section 301(p) of the FD&C Act.Further, because (b)(4) performed release testing, which constitutes manufacturing under 21 CFR 207.1, they were required to be registered with FDA under 21 CFR 207.17(a). A search of eDRLS confirms that neither laboratory is registered with FDA. Accordingly, Soraresal Cream and Equate Medicated Vaporizing Steam Liquid were manufactured, in part, in establishments not duly registered with FDA. Under section 502(o) of the FD&C Act, a drug is misbranded if it was manufactured in an establishment not duly registered under section 510, or if it was not included in a list required by section 510(j). Under section 301(a), it is a prohibited act to introduce or deliver for introduction into interstate commerce any drug that is misbranded.Complete, accurate, and up-to-date establishment registration and drug listing information is essential to promote and protect patient safety. FDA relies on establishment registration and drug listing information for several key programs, including drug establishment inspections, supply chain security, and post-market surveillance. Establishment registration and drug listing information is also widely used outside FDA for purposes such as electronic prescribing and electronic health records, insurance reimbursement, and patient education.It is your responsibility to ensure that all drugs manufactured at your establishment comply with all establishment registration and drug listing requirements under section 510 of the FD&C Act, 21 U.S.C. 360, 21 CFR Part 207, and all other applicable FDA regulations. Registration and listing information and instructions on how to properly register an establishment or submit drug listings can be found at Electronic Drug Registration and Listing Instructions.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at BioMylz Pvt. Ltd., located at #21 - D #21 - D Building No 1, Bengaluru, Karnataka, India, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3013697420 and ATTN: Frank Wackes.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:26-HFD-45-07-01Product:DrugsRecipient:Pratik Doshi, M.D.Alembic Pharmaceuticals Ltd.Alembic Research Centre Bioequivalence Facility, Alembic RoadNext to Bhailal Amin General Hospital GorwaVadodara 390003 GujaratIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 26-HFD-45-07-01Dear Dr. Doshi:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Alembic Research Centre in Vadodara, Gujarat, India, between March 3 and 7, 2025. The investigator representing FDA reviewed your conduct of a clinical in vivo bioequivalence study (Protocol (b)(4), “(b)(4)”) of the investigational drug (b)(4), performed for (b)(4).This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, the FDA investigator presented and discussed with you Form FDA 483, Inspectional Observations. We acknowledge receipt of your March 26, 2025, written response to the Form FDA 483.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated March 26, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, parts 312 (21 CFR 312) and 50 (21 CFR 50) governing the conduct of clinical investigations and the protection of human subjects.1 We wish to emphasize the following:You failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20].As a clinical investigator, you are required to obtain informed consent in accordance with 21 CFR part 50. FDA’s regulations at 21 CFR 50.20 state that, except as provided in 21 CFR 50.22, 50.23, and 50.24,2 no investigator may involve a human being as a subject in research covered by the regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. Under 21 CFR 50.20, “an investigator shall seek … [informed] consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.”You failed to seek informed consent for the above-referenced clinical investigation under circumstances that provided the prospective subject or representative with sufficient opportunity or information to consider whether to participate and that minimized the possibility of undue influence. Specifically, the ‘Nature and Purpose of this Study’ section of the informed consent form (ICF) stated, “This study is a clinical research project, but no part of it is of an experimental nature.” Stating that no part of the study is experimental may lead individuals to mistaken conclusions about whether the study is a “clinical investigation” as defined in 21 CFR 50.33 and 21 CFR 312.34. The lack of clarity on this point may lead individuals to mistaken conclusions about whether any such procedures are experimental – information that is required to be provided to subjects in accordance with the basic elements of informed consent found at 21 CFR 50.25(a)(1). Statements that do not clearly describe the experimental nature of a study may unduly influence individuals to agree to participate when they might not do so otherwise.In your March 26, 2025, written response to the Form FDA 483, you acknowledged the observation regarding the ICF statement and stated that the rationale for having the statement in the ICF was based on your firm’s understanding of, among other things, the nature and purpose of bioequivalence studies. However, you acknowledged that bioequivalence studies are considered experiments, in accordance with 21 CFR parts 312 and 50. You further stated that all information pertaining to the conduct of the study and the investigational products were adequately described in the ICF; that the Ethics Committee approved the ICF; and that the information was sufficient to avoid the possibility of coercion or undue influence on the subject’s decision to participate in the study.While we acknowledge that other information pertaining to the conduct of the study and the investigational product were described in the ICF, stating that “no part of it is of an experimental nature” created inconsistencies within the ICF, and these inconsistencies may lead individuals to mistaken conclusions about the type of study and its purpose. As a result, these inconsistences resulted in subjects’ not having sufficient opportunity to decide whether to participate in the study and may have unduly influenced the subjects’ decision to participate. As a result, you failed to obtain informed consent.In addition, in your written response, you stated that your site has taken the following corrective and preventive actions: (1) You revised the “Preparation of Informed Consent Form” Standard Operating Procedure (SOP) to include the definitions of a “clinical investigation” under 21 CFR 50.3 and 312.3; (2) you updated the “Informed Consent Form” template to remove the phrase “but no part of it is of an experimental nature”; (3) you trained clinical personnel on the revised SOP; and (4) you initiated an amendment, with Ethics Committee approval, to all ICFs of ongoing and planned studies to ensure compliance with the revised SOP.While we acknowledge the corrective and preventive actions that your site has taken, your written response is inadequate because you did not provide sufficient details about how you, as the clinical investigator, will ensure adequate compliance with the informed consent regulations at 21 CFR part 50. For example, while we acknowledge that you participated in training on the revised SOP, you did not participate in any training on FDA regulations governing the conduct of clinical research or the protection of human subjects. Additionally, although you stated that you initiated an amendment to all ICFs of ongoing and planned studies to ensure compliance with the revised SOP, your written response did not include the revised ICFs with Ethics Committee approval for all ongoing and planned studies. Without this information, we are unable to determine whether your corrective actions appear adequate to prevent similar violations in future clinical investigations.We emphasize that as the clinical investigator, you are ultimately responsible for compliance with all applicable FDA regulations governing the conduct of clinical investigations and the protection of human subjects, including obtaining legal effective informed consent from subjects before their enrollment. Your failure to obtain informed consent in accordance with 21 CFR part 50 before involving subjects in research jeopardizes the rights, safety, and welfare of subjects and raises concerns about whether subjects had an adequate opportunity to fully assess the risks and benefits of their participation in the clinical investigation.This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action without further notice to you. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Your written response, and any questions or concerns about this letter or the inspection, should be sent via email to the FDA at CDER-OSI-Communications@fda.hhs.gov.Sincerely yours,{See appended electronic signature page}David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationDavid C. Burrow Digitally signed by David C. BurrowDate: 7/10/2026 11:39:11 AM EDT______________________1 In accordance with 21 CFR 320.31(c), the provisions of 21 CFR parts 312 and 50 are applicable to this bioequivalence study in humans because Protocol (b)(4) was conducted under an Investigational New Drug application (IND).2 The exceptions provided in 21 CFR 50.22, 50.23, and 50.24 are not applicable here.3 In accordance with 21 CFR 50.3, “clinical investigation” means any experiment [emphasis added] that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the Act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Adminis-tration as part of an application for a research or marketing permit.4 In accordance with 21 CFR 312.3, “clinical investigation” means any experiment [emphasis added] in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.

Delivery Method:VIA Electronic MailProduct:Animal & VeterinaryDrugsRecipient:Mr. David L. RapyGeneral ManagerFareva AmboiseZone Industrielle 29, route des industries37530 Pocé-sur-CisseFranceIssuing Office:Center for Veterinary MedicineUnited StatesCenter for Drug Evaluation and Research (CDER)United StatesApril 10, 2026CMS Case: 723502WARNING LETTERDear Mr. Rapy:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fareva Amboise, FEI 3000234005, at Zone Industrielle 29, route des Industries 37 530 Pocé-sur-Cisse, France from September 8 to 16, 2025.This warning letter summarizes significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your October 7, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondences dated December 11, 2025, December 23, 2025, and February 6, 2026.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).Inadequate Smoke StudiesAirflow visualization studies performed for your Grade A (b)(4) aseptic filling line, which is used to fill animal drug products for the U.S. market, did not demonstrate unidirectional air flow and revealed multiple deficiencies in airflow patterns and aseptic practices. For example:During (b)(4) installation, air flowed from the operator (positioned in the Grade B area while leaning into the barrier) toward the (b)(4) intervention site where uncovered (b)(4) on the (b)(4) were exposed.• Air flowed upward towards the Grade B area when (b)(4) was (b)(4), leading to the (b)(4) and on top of (b)(4), rather than maintaining unidirectional flow away from critical surfaces.• Laminar flow patterns during interventions performed around the filling area showed a tendency to stagnate and flow upward in the area between (b)(4) where operators make tubing connections.• Airflow was turbulent with an (b)(4) flow while stoppers were transferred from the stopper bowl to the stoppering machine and over the conveyor moving open bottle.Furthermore, your firm has not conducted dynamic airflow studies during filling and stoppering operations. The airflow studies reviewed during the inspection do not include airflow patterns during filling of (b)(4) containers (b)(4) filled on the (b)(4) production line, demonstrating incomplete qualification of your aseptic processing conditions.Your response acknowledges inadequacies in the airflow studies reviewed during the inspection and references previous smoke studies (not provided during inspection) that purportedly confirm adequate airflow. However, you committed to conduct new dynamic smoke studies on the (b)(4) aseptic filling line under external consultant supervision and provided an "Evaluation of Smoke Studies" (December 8-19, 2025) in one of your response updates. The evaluation recognizes that (b)(4) has outdated equipment and environmental design causing non-conformities, including non-laminar flow issues that cannot be corrected through practice improvements alone, and proposes line improvements and procedural changes to mitigate the identified risks.Your response is inadequate. While your December 2025 smoke studies evaluation identifies critical non-conformities requiring correction, you provide no specific timelines or deadlines for implementing the recommended corrections. The reference to change control AMB-CC-2025-227 is insufficient without committed completion dates. Also of note, the document you identified as the "Risk assessment on smoke studies" does not appear to correspond to the document referenced in your response attachments. Without a risk assessment, there is no information regarding the impact of the identified deficiencies on sterile drug products manufactured in your aseptic processing areas.Poor Aseptic Technique and Cleanroom BehaviorPoor aseptic practices occurred during set up and filling operations of (b)(4) batches (b)(4) including the following:Inadequate handling of materials, sterile components and equipment:o An operator removed empty bottles from the Grade A area by hand into the Grade B area. Additionally, the operator later returned the bottles to the critical area for filling without disinfecting them.o An operator introduced a (b)(4) bag containing (b)(4) into the Grade A area without disinfection, then repeatedly reached over the unprotected sterile parts ((b)(4)) to make tubing connections.o An operator removed protective (b)(4) from sanitized equipment parts in the Grade B area, then transferred it into Grade A for installation.Inadequate personnel practiceso Failure to consistently use slow and controlled movements during aseptic operations and while performing (b)(4) connections.o Reaching over sterilized equipment and positioning of arms directly above sterile contact surfaces.o Reaching into and over sterile components and equipment, creating direct contamination potential for sterile product contact surfaces.In your response you committed to conducting a re-assessment of all aseptic practices. You proposed the implementation of specific actions to reduce risk during interventions to the Grade A area and periodic self-inspections by the production and QA managers. Additionally, you provided evidence of personnel re-training on aseptic behavior.Your response is inadequate because it did not investigate the impact of these poor aseptic practices on the sterile drugs you manufactured. Further, the response does not provide sufficient details regarding the frequency and scope of the proposed self- inspections to be implemented to address the lack of oversight of aseptic behavior of the operators.Inadequate Process Simulation (Media Fills)Your media fills do not adequately simulate commercial operations. For example, FDA investigators observed significantly more (b)(4) interventions during aseptic filling operations on September 8, 2025, and in their review of the aseptic filling of (b)(4) batch (b)(4) than those that were documented in the corresponding media fill records, which indicates your media fills do not simulate worst-case conditions.Additionally, complete information regarding the type, frequency, and timing of interventions was not consistently documented in the media fill or batch production records. For example, you performed numerous interventions during the filling of (b)(4) batch (b)(4) which you did not document in the batch record.Furthermore, you do not have written procedures for vial rejection (e.g., rejecting vials during interventions or after (b)(4).) You reject vials after (b)(4) during media fills, but your lack of written procedures means there is no basis to conclude this is representative of routine production. You also fail to keep records of such rejections during commercial batches, which prevents any meaningful comparison with your media fill.In response to this deficiency, you committed to establishing a (b)(4) process for interventions, add reminders for complete intervention documentation in batch records, analyze data to develop new media fill protocols, implement intervention batch documentation forms verified against video recordings, and establish new SOPs with operator training for vial removal activities.Your response is inadequate because it fails to address the potential impact of the observed deficiencies or propose interim measures to mitigate risk to product quality. Furthermore, your response does not address overall aseptic processing deficiencies, including but not limited to inadequate airflow studies, personnel behavior issues, and inadequate process simulations. When a media fill program fails to adequately account for contamination risk factors or accurately replicate actual drug product exposure conditions, it becomes difficult to properly evaluate the state of process control or provide adequate sterility assurance.Inadequate Monitoring of Personnel In Aseptic AreasYour firm failed to ensure adequate monitoring of personnel operating within the critical area. For example, personnel whose hands and forearms extend into the Grade A area — where open vials, exposed sterile stoppers, and sterile equipment surfaces are present — were held to Grade B requirements ((b)(4) alert, (b)(4) CFU action limits) when their hands were monitored upon exit. For example, on April 17, 2025, during aseptic filling of (b)(4), batch (b)(4)(US batch), (b)(4) CFU’s of Corynebacterium tuberculostearicum, were recovered on the right forearm of Personnel ID:(b)(6), who participated in the filling activities.You initiated a deviation to review (b)(4) batch (b)(4) and concluded that aseptic practices and environmental controls were compliant, despite the recovery of (b)(4) CFUs on an operator's forearm who had direct contact with the Grade A environment. You committed to implementing the use of (b)(4) to prevent (b)(4) under laminar flow, controlling (b)(4) and forearms to Grade A specifications, and improving the stopper bowl design to reduce interventions.Your response is inadequate because you failed to acknowledge that personnel monitoring requirements should be based on actual Grade A exposure and contamination risk rather than arbitrary area designations. You concluded that your practices were "compliant" despite clear evidence that an operator with (b)(4) CFUs on their forearm had direct contact with the Grade A environment during aseptic operations. You failed to provide an investigation into the contamination source or potential product impact to determine if batch (b)(4) or other batches processed by contaminated personnel pose sterility risks to distributed products. Additionally, you failed to provide documentation evidencing implementation of the proposed corrections such as revised personnel monitoring procedures and to establish interim controls or enhanced supervision.In response to this letter, provide the following:Comprehensive risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including an independent assessment that includes, but is not limited to: All human interactions within the ISO 5 area Equipment placement and ergonomics Air quality in the ISO 5 area and surrounding room Facility layout Personnel Flows and Material Flows (throughout all rooms used to conduct and support sterile operations)A detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe specific tangible improvements to be made to aseptic processing operation design and control.Your plan to ensure appropriate aseptic practices and cleanroom behavior during production. Include steps to ensure routine and effective supervisory oversight for all production batches. Also describe the frequency of quality unit (QU) oversight (e.g., audit) during aseptic processing and its support-operations.A thorough retrospective review and risk assessment that evaluates how poor aseptic technique and cleanroom behavior may have affected the quality and sterility of your drugs.Smoke studies under dynamic conditions, with thorough and complete evaluations of aseptic interventions and operator positioning within the critical filling areas. After you remediate your aseptic operation, provide smoke studies that visualize airflow and critically evaluate unidirectional airflow. Include a video of your dynamic smoke studies.A comprehensive summary of your remediated media fill program that ensures appropriate simulations of worst-case conditions in commercial manufacturing.2. Your firm failed to establish adequate control systems to prevent contamination during aseptic processing 211.42(c)(10)(v)Inadequate systems for cleaning and disinfectionYour aseptic processing operation is inadequately designed to prevent contamination of sterile drug products. For example, the stopper bowl equipment, which directly contacts (b)(4) container closure components, has parts that are permanently fixed to the machine and cannot be disassembled. This design prevents adequate cleaning and sterilization of critical contact surfaces.1Our investigators observed that equipment (b)(4) were disinfected and stored in a Grade C area, then transported through a Grade B area and installed in the Grade A area without re-disinfection. Additionally, your firm failed to maintain records of when equipment disinfection occurred2 and you lack cleaning validation data to support time limits for holding disinfected equipment prior to installation in the Grade A area.Your facility does not routinely use a sporicidal agent on equipment surfaces within the Grade A filling barrier. Further, your firm has not conducted or provided validated disinfection efficacy studies to demonstrate the effectiveness of disinfection procedures for all surfaces in the Grade A filling area. This includes filling machine (b)(4) constructed from (b)(4).3Moreover, during our inspection, apparent (b)(4), scratch marks and signs of wear were observed on the (b)(4) for the aseptic filling and capping lines. While you had performed the preventive maintenance (PM) on these equipment pieces, the preventive maintenance activities did not identify the damage on the equipment parts and corrective actions were not implemented until the deficiencies were noted during the inspection.You acknowledged a design flaw in your equipment and committed to creating a new stopper bowl part that your operators can sterilize and install, with plans to incorporate this intervention into upcoming smoke studies. You also committed to revising assembly procedures for the stopper bowl, training your operators on these updates, and implementing reinforced decontamination activities that include (b)(4) sporicidal (b)(4) treatments followed by surface monitoring to verify effectiveness. To address inadequate transport of (b)(4) from Grade C to Grade A areas, you committed to updating procedures that will require your personnel to sterilize or disinfect (b)(4) before entering Grade A environments, with particular emphasis on parts that contact products directly, and you committed to validate these disinfection procedures. You proposed implementing (b)(4) sporicidal decontamination in Grade A areas while revising procedures that define methodology and frequency. Regarding disinfection efficacy studies for all Grade A surface materials, you referenced an ongoing validation that your provider is conducting and will generate comprehensive validation data. Finally, you presented a (b)(4) during the inspection and committed to assessing all your aseptic process equipment for degradation risks, verifying your preventive maintenance program, and implementing equipment defect verification and correction during (b)(4).Your response to these observations is inadequate. While your response addresses the identified deficiencies, you failed to provide documentation evidencing the implementation of the proposed corrections or interim control measures such as validation protocols, revised procedures, or service provider contracts. You did not conduct an adequate risk assessment to determine if the drug products manufactured by your facility for the U.S. market are compromised for sterility. Additionally, we are concerned that your preventive maintenance program did not identify the improper equipment conditions, including scratches, cracks, and (b)(4), until these deficiencies were pointed out during our inspection. Your response lacks scientific justification for the proposed (b)(4) sporicidal treatment frequency and fails to adequately explain why routine sporicidal treatment was not previously considered necessary for aseptic operations. Furthermore, your preventive maintenance response does not provide sufficient scientific rationale for the proposed maintenance intervals and inadequately addresses how your previous maintenance program failed to detect obvious equipment defects that were readily apparent to our investigators. The absence of supporting documentation, combined with the failure to assess potential impact on distributed products and the systemic oversight failures in your maintenance program, demonstrates insufficient corrective action to ensure ongoing compliance with current good manufacturing practice requirements.In response to this letter, provide the following:Your corrective action and preventive action (CAPA) plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.3. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records, and you do not maintain a backup file of data. 21 CFR 211.68(b)Your systems do not have the appropriate controls to prevent data deletion and record modifications.For example, your firm uses (b)(4) particle counters to perform particle monitoring in classified areas. During the inspection on September 10, 2025, our investigator observed that operators could modify system dates, adjust alarm limits, and access settings without restriction. The equipment displayed that network user authentication was not enforced, and management confirmed that no controls were in place to ensure the integrity of printed data records.Review of electronic data stored on your particle counters revealed multiple instances where Grade A action limits for particle counts were exceeded. However, your firm could not produce original printed documentation of these failing results despite extensive searches of batch records and data storage locations. Initial failing particle count results in Grade A areas were not recorded in batch records. Instead, retests were performed, and only conforming retest results were retained and included in production documentation. There was no evidence in batch records of the original failing results or required corrective actions such as notifying operators or cleaning the area.Additionally, you lack adequate data backup and retention procedures. For example, your firm's vendor performed a calibration activity which deleted all electronic data prior to the calibration. You did not have backups of this data.You acknowledged the data integrity failures with your (b)(4) particle counters and proposed several corrective actions. You opened a deviation to document the incident and committed to retraining all personnel on data retention obligations. You purchased new (b)(4) equipment with electronic data collection capabilities that will be connected to a server, proposed to conduct a system-wide review of other in-process control equipment for similar upgrades, and to investigate the root cause of particulate contamination at the (b)(4) machine laminar airflow. You also committed to developing an investment plan for upgrading older equipment and eliminating reliance on paper-based data collection systems.Your response is inadequate because it fails to address the immediate and ongoing data integrity risks during the implementation timeline. Your response lacks sufficient interim controls to prevent data manipulation, provides no enhanced Quality Unit oversight of current (b)(4) operations, and offers only "retraining" as an immediate remedy for what appears to be data suppression. You did not commit to assessing the impact on already-released batches or implementing enhanced supervision during the interim period.In response to this letter, provide the following:A comprehensive, independent assessment of computer system performance and security. Provide a report that identifies vulnerabilities in design and controls, and a thorough corrective action and preventive action (CAPA) plan for each of your laboratory or production computer systems, which contains the following elements:o A list of all hardware (both standalone and networked) and software used.o Identification and evaluation of vulnerabilities in performance and security of all of these computer systems, including but not limited to their configurations, administrative rights, password controls, audit trails capabilities and state of implementation for each system, qualification/validation status, deviation history, backup capabilities, network requirements, completeness of data records, suitability of current hardware/software for its intended use(s), change management, and management oversight.o An Assessment of each system to determine if unique usernames and passwords are used.o An evaluation of your policies and procedures regarding computers and data governance with special emphasis on audit trails, prohibiting data deletion, and appropriate modifications of results. Specify how your firm prevents data deletion and undocumented/inappropriate modifications of data. Also describe how you ensure original data and information are always preserved. Provide your procedures for audit trail review. Provide requirements for data retention and backup for all laboratory and production systems.A summary of your interim controls to assure reliable performance and security while your CAPA plan is being implemented.4. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).You manufacture prescription (b)(4) dosage form human drug products used to treat various conditions including (b)(4). Your cleaning procedures for your (b)(4), non-dedicated manufacturing equipment was inadequate. For example,(b)(4) residues were observed on the gasket of the (b)(4) equipment.(b)(4) residues were observed inside the (b)(4) equipment.During the inspection you collected and analyzed samples of the residue. The active pharmaceutical ingredient (b)(4) was detected.In your response, you state that additional testing had been performed and confirmed the presence of (b)(4), an inactive ingredient which is found in multiple drug products. You then stated that there was no impact on the batches manufactured and distributed, as it was part of the formulation of multiple drug products.Your response is inadequate. The presence of (b)(4) from previous batches detected indicates the potential for active ingredients from previous batches to cross contaminate other drug products you manufactured. You failed to assess the impact of your inadequate cleaning processes on products that are currently on the market and within expiry. Furthermore, you failed to provide supporting data to demonstrate that your cleaning practices are sufficient to remove contaminants from surfaces of your drug product manufacturing equipment.It is essential that your facility and equipment are cleaned, and sanitary conditions are maintained, to ensure ongoing suitability for drug manufacturing, and to protect drug products from contamination.In response to this letter, provide:A summary of results from testing retains samples of all drug product batches within expiry manufactured on non-dedicated (b)(4) equipment. You should test all other active ingredients processed in your (b)(4) equipment. Additionally, provide your scientific rationale for any specification related to cross contamination levels. If testing yields an out-of-specification (OOS) result, indicate the corrective actions you will take, including notifying customers and initiating recalls.A comprehensive assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture more than one product.A CAPA plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all products and equipment; and all other needed remediations.Additional Guidance on Aseptic ProcessingSee FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice at https://www.fda.gov/media/71026/download).4Quality SystemsYour firm’s quality systems are inadequate. For guidance on establishing and maintaining CGMP-compliant quality systems, see FDA’s guidances: Q9 Quality Risk Management at https://www.fda.gov/media/167721/download and Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.You must correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA refusing admission of drugs manufactured at Fareva Amboise Zone Industrielle 29, route des industries 37530 Pocé-sur-Cisse - France under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Drugs that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CVM-483-Responses@fda.hhs.gov. Refer to the CMS Case number 723502 FEI 3000234005 and ATTN: Dayna I. Martínez when replying.Sincerely,/S/Dillard WoodyActing DirectorDivision of Drug ComplianceOffice Surveillance and ComplianceCenter for Veterinary Medicine/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research______________1 See also, 21 CFR 211.63 (equipment design).2 See also, 21 CFR 211.182 (equipment cleaning records).3 See also, 21 CFR 211.67 (equipment cleaning and maintenance).4 While this document does not specifically reference the Center for Veterinary Medicine, its contents may be helpful as sterile animal drugs and human drugs produced by aseptic processing are subject to the same CGMP requirements.

Delivery Method:Via Email Return Receipt RequestedReference #:320-26-102Product:DrugsRecipient:Mr. Rajesh GandhiChairmanAlmon Healthcare Private LimitedPlot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, BavalaAhmedabad 382240 GujaratIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-102July 13, 2026Dear Mr. Gandhi:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Almon Healthcare Private Limited, FEI 3030509366, at Plot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, Bavala, Ahmedabad, from February 9 to 13, 2026.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your March 6, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific deviations including, but not limited to, the following.1. Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP.Your quality unit (QU) failed to perform identity testing on incoming raw materials used in the manufacture of APIs (b)(4), which are intended for use in pharmacy compounding.Specifically, your firm intentionally accepted lots of (b)(4) that were deliberately mislabeled by your supplier as (b)(4). During the inspection, your QU admitted that this was a deliberate and ongoing practice since 2024 to circumvent your firm’s lack of a required (b)(4) license. You subsequently used this mislabeled and untested material to manufacture multiple batches of (b)(4) that you ultimately shipped to the United States. Furthermore, your QU relied on your supplier’s certificate of analysis without conducting supplier qualification as your standard operating procedure requires.In your response, you acknowledge the mislabeling practice, state you have since obtained the required (b)(4) license, and commit to performing identity testing of all future lots of (b)(4). You also state that a retrospective reevaluation of residual solvent chromatographic data confirms that peaks previously observed in the affected (b)(4) batches are attributable to (b)(4).Your response is inadequate. Your analytical conclusions are unsubstantiated because your response does not provide the supporting chromatograms or results from your identity tests. Furthermore, you do not provide a risk assessment for batches already distributed to the United States. Your response also does not address the systemic quality failure that allowed your firm to knowingly accept and recode mislabeled materials without performing identity testing. Finally, you fail to propose any substantive corrective actions to remediate your supplier qualification program to prevent a recurrence of this critical failure.Without adequate testing, you do not have scientific evidence that incoming materials conform to appropriate specifications prior to use in the manufacture of your drugs. As a manufacturer, you have a responsibility to sample, test, and examine incoming materials before use in production to assure adequate quality. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.Your practice of receiving (b)(4) mislabeled as (b)(4) poses a significant safety risk to personnel who may handle the material without knowing its true identity. Due to lack of awareness, workers may fail to take the precautions necessary to prevent exposure. (b)(4) is acutely toxic to humans and has caused fatal poisoning incidents worldwide.Furthermore, an adequate QU overseeing all elements of CGMP is necessary to consistently ensure drug quality. FDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP, including the sections on quality oversight. See FDA’s guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of API at https://www.fda.gov/media/71518/download.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all productso Also describe how top management supports quality assurance and reliable operations including, but not limited to timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.2. Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your intermediate and API conform to established standards of quality and purity.Your firm failed to validate or adequately verify multiple test methods used for testing key starting materials and finished APIs. Specifically, you did not validate the in-house analytical methods, including the stability-indicating methods, used to support the (b)(4) retest dates for your products shipped to the United States. Furthermore, your firm failed to adequately implement and verify an analytical method transferred from your contract testing laboratory CTL) used for routine testing and stability studies of (b)(4). Your implemented method was unable to detect multiple unknown impurities that your CTL’s validated method identified.In your response, you commit to executing forced degradation studies to demonstrate your methods are stability-indicating and to reassessing the validity of the assigned (b)(4) retest dates for the APIs shipped to the United States. You also commit to executing validation and verification protocols for compendial and in-house methods. You attribute the discrepancy in impurity detection in (b)(4) to an incorrectly set processing threshold and provide reprocessed data to suggest your results are now comparable.Your response is inadequate because it fails to comprehensively assess your laboratory systems to ensure that all test methods are appropriately validated or verified. You have not established any interim controls for ongoing production while you conduct your retrospective review of batches tested with unvalidated methods. Additionally, while you attempt to explain the threshold differences between the CTL and the in-house verification study for (b)(4), you fail to address whether the methods are truly equivalent.Without an appropriate laboratory and stability-indicating methods, you lack adequate scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.In response to this letter, provide:A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A list of validated/verified chemical specifications, including test methods, used to analyze each batch of your drug products before a lot disposition decision.o An action plan and timelines for conducting full chemical testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.A comprehensive assessment and corrective action and preventive action plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability-indicating methodso Stability studies for each drug product in its marketed container-closure system before distribution is permittedo An ongoing program in which representative batches of each product are added each year to the program to determine the shelf-life claim remains valido Detailed definition of the specific attributes to be tested at each station (timepoint)o All procedures that describe these and other elements of your remediated stability programConfirm the retest dates for (b)(4) using the revalidated stability-indicating method. This reassessment should ensure that all previously assigned retest dates are accurate.3. Failure to clean equipment to prevent contamination or carry-over of a material that would alter the quality of the intermediates and API beyond the official or other established specifications.Your firm failed to adequately clean and maintain non-dedicated API manufacturing equipment used to manufacture as many as (b)(4) different APIs. For example, our investigator observed (b)(4) and (b)(4) particles on product contact surfaces, including the lid and (b)(4) of (b)(4), and (b)(4) liquid draining from the (b)(4) even though the (b)(4) was documented as “empty and cleaned.” Additionally, your firm failed to maintain cleaning records for a non-dedicated (b)(4) product transfer pipe.Your cleaning verification report for (b)(4) addressed only batch-to-batch cleaning. It did not address product changeover. It also lacked scientific justification for product selection and residue limit calculations based on solubility, difficulty of cleaning, and toxicity, as required by your cleaning validation procedure. Your firm affirmed to our investigator that no formal cleaning validation has been performed and that you have not established a maximum allowable carryover limit as required by your procedure.In your response, you attribute the observed residues on the (b)(4) to the previous batch of the same non-U.S. API, explaining that only a “gross cleaning” is performed between batches during a (b)(4). You conclude there was no risk of carryover. You assert that the (b)(4) transfer pipe is dedicated to a (b)(4) and also conclude there is no cross-contamination risk and confirm you do not use cleaning logs.Furthermore, you state that you “executed cleaning validation/verification activities for selected products” manufactured on shared equipment.Your response is inadequate because it does not provide assurance that your cleaning processes are adequate to prevent cross-contamination and carryover risks. It addresses only the (b)(4) particles observed in the (b)(4), attributing them to a non-U.S. API campaign, while failing to test the observed (b)(4) liquid and other particle deposits. You did not expand your investigation to other equipment or conduct a retrospective review of released batches to assess product impact.Your claim that the (b)(4) transfer pipe is dedicated to a (b)(4) is unsubstantiated and contradicts information provided during the inspection. Further, you do not explain why cleaning validation was limited to selected products, nor do you provide supporting documentation to support or demonstrate that your cleaning practices adequately remove product residues.Inadequately cleaned and maintained manufacturing equipment can lead to potential cross-contamination that could compromise your API’s quality and safety.In response to this letter, provide:A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment of whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture intermediates and API products.Appropriate improvements to your cleaning validation program with special emphasis on incorporating conditions identified as worst case in your API manufacturing operations. This should include but not be limited to identification and evaluation of all worst-case:o Drugs with higher toxicitieso Drugs with higher potencieso Drugs with lower solubility in their cleaning solventso Drugs with characteristics that make them difficult to cleano Swabbing locations for areas that are most difficult to cleano Maximum hold times before cleaningA summary of updated standard operating procedures that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.CGMP Consultant RecommendedBased upon the nature of the deviations we identified at your firm, you should engage a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on June 9, 2026.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Almon Healthcare Private Limited located at Plot No 4, Sankalp Industrial Estate, Behind Kerala GIDC, Bavala, Ahmedabad, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3030509366 and ATTN: Jamie Dion.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA Electronic MailReference #:320-26-101Product:DrugsRecipient:Mr. C. Srinivas RaoPartnerShimoga ChemicalsW57A, MIDC, KupwadSangli 416436 MaharashtraIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-101July 13, 2026Dear Mr. Rao:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Shimoga Chemicals, FEI 3033881432, at W57A, MIDC, Kupwad, Sangli, Maharashtra, 416436, India, from January 19 to 23, 2026.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your February 10, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific deviations including, but not limited to, the following.1. Failure to ensure that all specifications, sampling plans, test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity.Your firm manufactures the API, clomiphene citrate USP for U.S. distribution, intended for pharmacy compounding.Data Integrity ConcernsYour firm failed to establish adequate controls over analytical testing data. Multiple instances of unreported sample injections for related substances and assay testing by high performance liquid chromatography (HPLC) were not documented in laboratory batch records. For example, clomiphene citrate USP batch CC/005/24-25 had an unreported injection with an out-of-specification (OOS) assay result of (b)(4)% (specification: (b)(4)%); however, the reported injection result of (b)(4)% was documented in the batch record. Additionally, because your firm lacked procedures for electronic data review and your quality unit (QU) did not review the electronic data, this batch was subsequently released and distributed to the U.S. market.Without reliable analytical data, there is no assurance that distributed API batches meet identity, strength, quality, or purity specifications.Your response is inadequate. In your response, you acknowledge undocumented trial injections, unreported analytical data, discarded printouts, and inadequate review of electronic laboratory records. You also commit to a retrospective review of all U.S. batches, including electronic data and documentation. You further mention hiring a third-party data integrity expert. However, your response does not describe a thorough retrospective investigation into the OOS result for batch CC/005/24-25 distributed to the U.S. market.Sampling and Control Procedures ConcernsYour firm lacked adequate sampling procedures and records for clomiphene citrate USP in that batch records did not specify appropriate sampling instructions, quantities, or locations. For example, in (b)(4)-batches (b)(4), the batch records do not specify the sample quantity, the location of sampling, the sampling method, or whether sampling occurred before or after (b)(4). During the inspection, your production manager stated quality control (QC) samples were collected after (b)(4) the (b)(4)-batches, and samples were routinely collected from arbitrary locations from (b)(4). Furthermore, your QC manager stated in-process testing occurred only when the owner provided samples.Without defined and documented sampling instructions, testing results may be unreliable to confirm batch-to-batch quality or to detect manufacturing failures.Your response is inadequate. You do not describe an adequate sampling program or an evaluation of the impact of inadequate sampling.Method Verification ConcernsYour firm did not perform verification studies for any test methods, including but not limited to identification, related substances by HPLC, residual solvent, and assay by HPLC for clomiphene citrate USP. For example, your firm failed to verify the residual solvent method used by your contract testing laboratory. Additionally, during the inspection, your QC manager confirmed that no method verification has been performed for any of the test methods used for clomiphene citrate USP.Unverified test methods may not accurately measure product quality attributes, and failing results may go undetected.Your response is inadequate. In your response, you state you will validate your test methods and you will create a new procedure that ensures future methods will be validated. However, you do not discuss retrospective retain sample testing using appropriately verified methods by a qualified third-party laboratory.In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A retrospective, independent review of all invalidated OOS (including in-process and release/stability testing) results for U.S. API for the last three years from the initial date of inspection, and a report summarizing the findings of the analysis, including the following for each OOS:o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all OOS results with inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.A comprehensive review and remediation plan for your OOS result investigation systems. The corrective action and preventive action (CAPA) should include but not be limited to addressing the following:o QU oversight of laboratory investigationso Identification of adverse laboratory control trendso Resolution of causes of laboratory variationo Initiation of thorough investigations of potential manufacturing causes, whenever a laboratory cause cannot be conclusively identifiedo Adequate scoping of each investigation and its CAPAo Revised OOS investigation procedures with these and other remediationsA comprehensive, independent assessment of your in-process monitoring and sampling operations, focusing on each upstream process step that can introduce variability. Provide your remediation plan to improve: (1) in-process detection of variation, (2) upstream controls, and (3) sampling plans.Improved in-process testing and monitoring to enhance detection of variation during production of each batch. Include remediated in-process quality standards, including but not limited to enhanced sampling, that will more robustly monitor upstream process control. Describe how the improvements will ensure early detection of process variation and manufacturing defects, and prevent consumer exposure to substandard quality drug products.2. Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.Inadequate Process ValidationYour firm failed to establish adequate process validation for clomiphene citrate USP and its key starting materials. Your process validation reports do not accurately reflect actual manufacturing practices. For example, your validation reports fail to address the (b)(4) operation. Also, your validations do not address routine hold times. For example, (b)(4) batch (b)(4) was stored for approximately (b)(4) without defined hold-time limits or supporting studies.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and to evaluate batches to determine whether an initial state of control has been established. See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.Your response is inadequate. You acknowledge the lack of appropriate process validation, and you commit to initiating validation protocols. You also state that a retrospective batch record review has been initiated for all clomiphene citrate USP batches shipped to the U.S. market. However, your response lacks sufficient details to determine whether your response is adequate. Specifically, you have not defined the scope of your record review, the acceptance criteria for your validation protocols, or the corrective actions to be taken if discrepancies are identified.Inadequate Cleaning ProceduresYour firm also lacked robust and reproducible cleaning procedures for non-dedicated equipment used in the manufacture of the API clomiphene citrate USP, including (b)(4). Specifically, your acceptance criteria for cleaning were not adequately defined and justified. Your cleaning procedures lacked specificity regarding cleaning methods, materials, contact times, and verification requirements. During the inspection, your firm’s management stated that only “(b)(4) water” is used for all equipment cleaning regardless of product, which is inconsistent with your written cleaning procedures.Without adequate cleaning validation, there may be a risk of cross-contamination between batches of API.Your response is inadequate. In your response, you commit to performing a cleaning validation and risk assessment for shared equipment. However, you fail to provide adequate details regarding cleaning validation or an appropriate cross-contamination risk assessment for shared equipment.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.A timeline for performing appropriate process performance qualification for each of your marketed API. Also provide a risk assessment and any follow up actions to be taken for the distributed API produced without performing any process validation studies.Process performance protocol(s), and written procedures for qualification of equipment and facilities.Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include but not be limited to identification and evaluation of all worst-case:o Drugs with higher toxicitieso Drugs with higher drug potencieso Drugs of lower solubility in their cleaning solventso Drugs with characteristics that make them difficult to cleano Swabbing locations for areas that are most difficult to cleano Maximum hold times before cleaningIn addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new API.A summary of updated standard operating procedures that ensure an appropriate program is in place for verification and validation of cleaning procedures for API, processes, and equipment.3. Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.Investigation HandlingYour QU failed to ensure that discrepancies and potential OOS events were adequately investigated. Your firm has manufactured and distributed approximately (b)(4) batches since April 2023. While your firm has not documented any OOS investigations, out-of-trend investigations, or laboratory incidents over at least the last two years, during the inspection, our investigators identified multiple events that should have triggered formal investigations, including the unreported OOS assay result for batch CC/005/24-25.Without adequate investigations, quality failure may go undetected and unresolved.Your response is inadequate. While you acknowledge discrepancies and potential OOS events were not adequately investigated, you do not provide a commitment to conduct any formal OOS investigation for batch CC/005/24-25.Stability Program DeficienciesYour QU failed to ensure that stability data adequately supports the assigned (b)(4) expiry date for clomiphene citrate USP. Your firm lacked raw test data, electronic or hardcopy, to support the results of your long-term stability study. In addition, while your stability management procedure requires that at least one commercial batch be placed on stability annually, your firm only placed batches on stability in 2021, 2022, and 2023. Your firm failed to place any U.S. batches manufactured in 2025 and 2026 on stability. Further, stability samples were stored in packaging that differed from the commercial container-closure system. This packaging has not been evaluated for equivalence.Without complete stability data, there is no assurance that the API will maintain all quality attributes through expiry.Your response is inadequate. You state that the ongoing stability study continues, but you fail to address the absence of raw data from the foundational 2015 study or your failure to place commercial batches on stability annually, as required by your own procedure.CGMP Training ConcernsYour QU failed to ensure that manufacturing personnel were adequately trained. For example, an analyst who performed unreported injections lacked documented laboratory training and CGMP training. Additionally, no training records were available for a production operator who performed (b)(4) operations on a batch in U.S. distribution.Using untrained personnel may create a systemic risk, potentially resulting in quality failures.Your response is inadequate. You acknowledge the use of untrained or insufficiently trained personnel, but you provide only a general commitment to retraining. This commitment lacks a specific, documented training matrix, a training schedule, or qualification criteria for affected personnel.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriateo Provisions for QU oversight throughout your operations, to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the QU disposition decisiono Oversight and approval of investigations and discharging of all other QU duties, to ensure identity, strength, quality, and purity of all productsA comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include but not be limited to:o Stability-indicating methodso Stability studies for each drug product in its marketed container-closure system before distribution is permittedPosition descriptions that outline defined qualifications for key personnel, particularly within the QU, to confirm appropriate assignment of responsibilities.Evidence that trained skills are being applied in day-to-day operations, including any managerial oversight mechanisms used to verify on-the-job performance.Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download, Q9(R1) Quality Risk Management https://www.fda.gov/media/167721/download, and ICH Q10 Pharmaceutical Quality System at https://www.fda.gov/media/71553/download.Data Integrity RemediationYour quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA's guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.We acknowledge your commitment to engaging an independent third-party data integrity consultant to audit your operation and assist in meeting FDA requirements.In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third-party.o An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility's operations in which you discovered data integrity deficiencies.o A comprehensive retrospective evaluation of the nature of the testing data integrity deficiencies. We recommend that a qualified third-party with specific expertise in the area where potential breaches were identified should evaluate all occurrences.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global CAPA plan. Your strategy should include:o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate, including analytical data, manufacturing records, and all data submitted to FDA.o A comprehensive description of the root causes of your data integrity lapses, including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.o Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, and enhanced complaint monitoring.o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company's data.o A commitment to have a qualified consultant conduct extensive annual audits, for at least two years, to assist in evaluating CAPA effectiveness after you have executed your data integrity remediation protocol.o Inform FDA if you will be hiring a chief integrity officer who is fully empowered to receive anonymous complaints from employees reporting data integrity concerns and with the authority to ensure any potential breach is promptly investigated (by an independent quality assurance function, along with expertise from outside entities whenever needed).A status report for any of the above activities already underway or completed.Drug RecallOn May 14, 2026, you issued a voluntary recall of clomiphene citrate USP due to deficiencies with your quality system and data integrity concerns. The company announcement was posted to the FDA website: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=221115.Additional API CGMP GuidanceFDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP. See FDA’s guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of API at https://www.fda.gov/media/71518/download.CGMP Consultant RecommendedBased upon the nature of the deviations we identified at your firm, you should engage a consultant qualified to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA before you pursue resolution of your firm's compliance status with FDA.Your use of a consultant does not relieve your firm's obligation to comply with CGMP. Your firm's executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on June 2, 2026.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.Failure to address any deviations may also result in the FDA continuing to refuse admission of articles manufactured at Shimoga Chemicals, at W57A, MIDC, Kupwad, Sangli, Maharashtra, 416436, India, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3033881432 and ATTN: Christopher M. Jenner.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailProduct:DrugsRecipient:Mr. Luke C. BlotskyCEOMineral BioSciences, LLC4050 S Sarival AveGoodyear, AZ 85338-3233United StatesIssuing Office:Human Foods ProgramUnited StatesJune 5, 2026WARNING LETTERCMS #724745Dear Mr. Blotsky:The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 4050 S Sarival Ave, Goodyear, AZ, on November 12-24, 2025. Based on inspectional findings and subsequent review of your websites https://mineralbiosciences.com/ and https://protectcells.com/, and your Facebook and Instagram social media pages at https://www.facebook.com/ProtectCells/ and https://www.instagram.com/p/BYR6AmlDlx4/, we have identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA's home page at www.fda.gov.At the conclusion of the inspection on November 24, 2025, our investigator provided you with a Form FDA 483, Inspectional Observations (FDA 483). We acknowledge receipt of your responses dated December 18, 2025, April 13, 2026, April 30, 2026, and May 1, 2026, and we address your responses below.Unapproved New DrugsFDA reviewed your websites at the Internet addresses https://mineralbiosciences.com/ and https://protectcells.com/ in May 2026 and determined that you take orders on the website https://protectcells.com/ for your products Totala Fulvic Ionic Mineral Complex and Ionicell. We also reviewed your social media pages on Facebook (https://www.facebook.com/ProtectCells/) and Instagram (https://www.instagram.com/p/BYR6AmlDlx4/) in March 2026, where you direct consumers to your website, https://protectcells.com/, to purchase your products. Claims on your social media webpages establish that your Totala Fulvic Ionic Mineral Complex and Ionicell products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.Examples of some of the claims that provide evidence that your products are intended for use as drugs include:Totala Fulvic Ionic Mineral Complex AND Ionicell“Did you know Higher A1C levels are linked to diabetes complications? But did you also know that case reports have shown that Ioniplex can help control post-prandial blood sugar levels?” Note: Ioniplex is an ingredient in both the Totala and Ionicell products. (https://www.facebook.com/ProtectCells/, from a post dated February 24, 2022)Totala Fulvic Ionic Mineral Complex AND Ionicell“Ioniplex has been clinically shown to repair and stimulate the body at the cellular level, leading to better glucose management.” Note: Ioniplex is an ingredient in both the Totala and Ionicell products. (https://www.facebook.com/ProtectCells/, from a post dated January 29, 2021)Totala Fulvic Ionic Mineral Complex“[H]as been taking Totala … and has noticed not only a drop in his blood pressure, but less pain in his joints…” (https://www.instagram.com/p/BYR6AmlDlx4/, from a post dated February 23, 2018)Ionicell“[H]as been taking IoniCell for several weeks and has already noticed a drop in her daily glucose levels and fasting glucose levels.” (https://www.instagram.com/p/BYR6AmlDlx4/, from a post dated February 6, 2018)Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.Misbranded DrugsA drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.Your products Totala Fulvic Ionic Mineral Complex and Ionicell are intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Totala Fulvic Ionic Mineral Complex and Ionicell fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)].Adulterated Dietary SupplementsThe inspection of your facility on November 12-24, 2025, identified serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the Totala Fulvic Ionic Mineral Complex Lemon Lime and Ionicell dietary supplement products manufactured at your facility to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. Thus, in addition to being unapproved new drugs and misbranded drugs, your Totala Fulvic Ionic Mineral Complex Lemon Lime and Ionicell products are also adulterated dietary supplements under section 402(g)(1) of the Act.Your significant violations of the CGMP requirements are as follows:1. You failed to meet sanitation requirements that apply to your physical plant and grounds under 21 CFR 111.15. Specifically:You failed to maintain your physical plant in a clean and sanitary condition and in repair sufficient to prevent components, dietary supplements, or contact surfaces from becoming contaminated, as required by 21 CFR 111.15(b). For example, from November 12-13, 2025, our investigator observed insulation hanging from the ceiling, one light casing which appeared to be taped with water leaking from it, two holes in your wall exposing outside elements, and multiple doors, including bay doors, with opening gaps allowing light to shine into your facility.You failed to take effective measures to exclude pests from the physical plant and to protect against contamination of components, dietary supplements, and contact surfaces on the premises by pests, as required by 21 CFR 111.15(d)(2). For example, on November 13, 2025, our investigator reviewed your pest control records for April 2025 through November 2025 and observed several occasions in which a pest control technician documented interior stations with apparent rodent activity, including inside the (b)(4) room, (b)(4) room where finished products are stored, and in the ambient warehouse. In addition, our investigator observed multiple exit doors propped open to the outside.During the inspection, you stated that you would create a risk assessment based on your assessment of these observations and that you were already in the process of making certain changes, such as (b)(4). We will evaluate the adequacy of your corrective actions during our next inspection.2. Your quality control personnel failed to approve or reject all processes, specifications, written procedures, controls, tests, and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). Specifically:Your component specifications for (b)(4) had not been signed and approved by your quality control personnel.We have reviewed your responses to the FDA 483, dated December 18, 2025, and April 30, 2026, in which you stated that your raw material specifications will be signed, reviewed, and approved by quality control personnel. However, we are unable to evaluate the adequacy of your response because you did not provide documentation supporting that your quality control personnel have approved your raw material specifications.3. Your written batch production records (BPRs) did not include complete information relating to the production and control of each batch, as required by 21 CFR 111.255(b), because they did not include all information required to be in a BPR under 21 CFR 111.260. Specifically, your firm’s BPRs for the dietary supplement products Totala Fulvic Ionic Mineral Complex Lemon Lime and Ionicell did not include the following required information:The time of the maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross-reference to records where this information is retained. [21 CFR 111.260(c)]The initials of the person responsible for weighing or measuring each component used in the batch. [21 CFR 111.260(j)(2)(i)]The initials of the person responsible for verifying the weight or measure of each component used in the batch. [21 CFR 111.260(j)(2)(ii)]The initials of the person responsible for adding the component to the batch. [21 CFR 111.260(j)(2)(iii)]The initials of the person responsible for verifying the addition of components to the batch. [21 CFR 111.260(j)(2)(iv)].We have reviewed your responses to the FDA 483, dated December 18, 2025, and April 30, 2026, in which you stated that the batch production records will be updated. However, we are unable to evaluate the adequacy of your response because you did not provide documentation supporting that your batch production records have been updated.4. Your firm failed to qualify certain suppliers by establishing the reliability of the suppliers’ certificates of analyses through confirmation of the results of the suppliers’ tests or examinations, in accordance with 21 CFR 111.75(a)(2)(ii)(A). Specifically, your firm relies on certificates of analyses to determine that component specifications for identity, purity, strength, composition, and limits on contamination are met, and you did not conduct testing on your (b)(4) dietary ingredients to establish the reliability of the suppliers’ certificates of analyses before use.We have reviewed your responses to the FDA 483, dated December 18, 2025, and April 30, 2026, in which you stated, “suppliers will be qualified establishing the reliability of the supplier’s certification of analysis through confirmation of the results of their tests or examinations.” On May 1, 2026, you provided component specification sheets that include instructions to confirm suppliers’ certificates of analyses with testing; however, we are unable to evaluate the adequacy of your response because you did not provide documentation supporting that the relevant suppliers have been qualified.This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.We also have the following comment:21 CFR 111.75(a)(2) does not allow firms to rely on a certificate of analysis to confirm the identity of a dietary ingredient. Rather, under 21 CFR 111.75(a)(1)(i), you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, prior to using a component (or submit an exemption petition under 21 CFR 111.75(a)(2)(ii)). However, your component specification sheets submitted on May 1, 2026, for your (b)(4) dietary ingredients state that component identity testing will be conducted (b)(4) instead of every time the component is used.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.Your written reply should be directed to Rebecca Allen, Compliance Officer, United States Food and Drug Administration, Human Foods Program, Office of Enforcement, 5001 Campus Drive, College Park, Maryland 20740-3835 or via email at HFP-OCE-DietarySupplements@fda.hhs.gov. Please reference CMS #724745 on any submissions and within the subject line of any emails to us. If you have any questions, you may email at HFP-OCE-DietarySupplements@fda.hhs.gov.Sincerely,/S/Maria S. Knirk, JD, MBADirector, Office of EnforcementOffice of Compliance and EnforcementHuman Foods Program

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:26-HFD-45-07-01Product:DrugsRecipient:Pratik Doshi, M.D.Pratik Doshi, M.D. / Alembic Pharmaceuticals Ltd.Alembic Research Centre Bioequivalence Facility, Alembic RoadNext to Bhailal Amin General Hospital GorwaVadodara 390003 GujaratIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 26-HFD-45-07-01Dear Dr. Doshi:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Alembic Research Centre in Vadodara, Gujarat, India, between March 3 and 7, 2025. The investigator representing FDA reviewed your conduct of a clinical in vivo bioequivalence study (Protocol (b)(4), “(b)(4)”) of the investigational drug (b)(4), performed for (b)(4).This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, the FDA investigator presented and discussed with you Form FDA 483, Inspectional Observations. We acknowledge receipt of your March 26, 2025, written response to the Form FDA 483.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated March 26, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, parts 312 (21 CFR 312) and 50 (21 CFR 50) governing the conduct of clinical investigations and the protection of human subjects.1 We wish to emphasize the following:You failed to obtain informed consent in accordance with the provisions of 21 CFR part 50 [21 CFR 312.60 and 21 CFR 50.20].As a clinical investigator, you are required to obtain informed consent in accordance with 21 CFR part 50. FDA’s regulations at 21 CFR 50.20 state that, except as provided in 21 CFR 50.22, 50.23, and 50.24,2 no investigator may involve a human being as a subject in research covered by the regulations unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. Under 21 CFR 50.20, “an investigator shall seek … [informed] consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.”You failed to seek informed consent for the above-referenced clinical investigation under circumstances that provided the prospective subject or representative with sufficient opportunity or information to consider whether to participate and that minimized the possibility of undue influence. Specifically, the ‘Nature and Purpose of this Study’ section of the informed consent form (ICF) stated, “This study is a clinical research project, but no part of it is of an experimental nature.” Stating that no part of the study is experimental may lead individuals to mistaken conclusions about whether the study is a “clinical investigation” as defined in 21 CFR 50.33 and 21 CFR 312.34. The lack of clarity on this point may lead individuals to mistaken conclusions about whether any such procedures are experimental – information that is required to be provided to subjects in accordance with the basic elements of informed consent found at 21 CFR 50.25(a)(1). Statements that do not clearly describe the experimental nature of a study may unduly influence individuals to agree to participate when they might not do so otherwise.In your March 26, 2025, written response to the Form FDA 483, you acknowledged the observation regarding the ICF statement and stated that the rationale for having the statement in the ICF was based on your firm’s understanding of, among other things, the nature and purpose of bioequivalence studies. However, you acknowledged that bioequivalence studies are considered experiments, in accordance with 21 CFR parts 312 and 50. You further stated that all information pertaining to the conduct of the study and the investigational products were adequately described in the ICF; that the Ethics Committee approved the ICF; and that the information was sufficient to avoid the possibility of coercion or undue influence on the subject’s decision to participate in the study.While we acknowledge that other information pertaining to the conduct of the study and the investigational product were described in the ICF, stating that “no part of it is of an experimental nature” created inconsistencies within the ICF, and these inconsistencies may lead individuals to mistaken conclusions about the type of study and its purpose. As a result, these inconsistences resulted in subjects’ not having sufficient opportunity to decide whether to participate in the study and may have unduly influenced the subjects’ decision to participate. As a result, you failed to obtain informed consent.In addition, in your written response, you stated that your site has taken the following corrective and preventive actions: (1) You revised the “Preparation of Informed Consent Form” Standard Operating Procedure (SOP) to include the definitions of a “clinical investigation” under 21 CFR 50.3 and 312.3; (2) you updated the “Informed Consent Form” template to remove the phrase “but no part of it is of an experimental nature”; (3) you trained clinical personnel on the revised SOP; and (4) you initiated an amendment, with Ethics Committee approval, to all ICFs of ongoing and planned studies to ensure compliance with the revised SOP.While we acknowledge the corrective and preventive actions that your site has taken, your written response is inadequate because you did not provide sufficient details about how you, as the clinical investigator, will ensure adequate compliance with the informed consent regulations at 21 CFR part 50. For example, while we acknowledge that you participated in training on the revised SOP, you did not participate in any training on FDA regulations governing the conduct of clinical research or the protection of human subjects. Additionally, although you stated that you initiated an amendment to all ICFs of ongoing and planned studies to ensure compliance with the revised SOP, your written response did not include the revised ICFs with Ethics Committee approval for all ongoing and planned studies. Without this information, we are unable to determine whether your corrective actions appear adequate to prevent similar violations in future clinical investigations.We emphasize that as the clinical investigator, you are ultimately responsible for compliance with all applicable FDA regulations governing the conduct of clinical investigations and the protection of human subjects, including obtaining legal effective informed consent from subjects before their enrollment. Your failure to obtain informed consent in accordance with 21 CFR part 50 before involving subjects in research jeopardizes the rights, safety, and welfare of subjects and raises concerns about whether subjects had an adequate opportunity to fully assess the risks and benefits of their participation in the clinical investigation.This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action without further notice to you. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Your written response, and any questions or concerns about this letter or the inspection, should be sent via email to the FDA at CDER-OSI-Communications@fda.hhs.gov.Sincerely yours,{See appended electronic signature page}David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationDavid C. Burrow Digitally signed by David C. BurrowDate: 7/10/2026 11:39:11 AM EDT______________________1 In accordance with 21 CFR 320.31(c), the provisions of 21 CFR parts 312 and 50 are applicable to this bioequivalence study in humans because Protocol (b)(4) was conducted under an Investigational New Drug application (IND).2 The exceptions provided in 21 CFR 50.22, 50.23, and 50.24 are not applicable here.3 In accordance with 21 CFR 50.3, “clinical investigation” means any experiment [emphasis added] that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the Act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Adminis-tration as part of an application for a research or marketing permit.4 In accordance with 21 CFR 312.3, “clinical investigation” means any experiment [emphasis added] in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.

　根据《国家药监局综合司关于开展化妆品个性化服务第二阶段试点工作的通知》精神和我局工作要求，经资料审查和现场评估，同意以下企业自2026年7月17日起开展牙膏个性化服务试点工作。　　试点企业：重庆登康口腔护理用品股份有限公司　　住所地址：重庆市江北区海尔路389号　　个性化服务场所地址：重庆市江北区海尔路389号                              　　　　　　　　　　　　　　　　　　　　　　　　　　重庆市药品监督管理局                                　　　　　　　　　　　　　　　　　　　　　　　　　2026年7月20日

  2025年3月，《中共中央办公厅国务院办公厅关于进一步强化食品安全全链条监管的意见》（以下简称《意见》）印发以来，各地区各有关部门在积极推动全链条监管落地落实工作中，涌现出一批有力度、有深度、有效度的创新做法。为分享交流经验、创新全链条监管实践，国务院食安办收集整理了一批典型案例，现公布如下。  案例一：浙江省温州市构建食用农产品市场销售全链条数字化监管体系  温州市依托“浙食链”平台，在全国率先探索食用农产品市场销售全链条数字化监管体系建设，着力破解产地准出与市场准入衔接不畅、传统纸质追溯效率低等难题。  一是推进准入准出数字化。推动“浙农码”生产信息与“浙食链”流通信息双向互通，实现地产农产品“两码贯通”；在全国率先试点猪肉全链条无纸化追溯改革，将动物检疫合格证明融入“浙食链”溯源码，全市生猪定点屠宰场、农贸市场实现“浙食链”全覆盖。  二是推进检测追溯数字化。2023年7月在全国率先实现农批市场数字化追溯全覆盖，将产地信息、市场快检信息与交易信息自动融合，一键推送至下游。温州菜篮子农批市场已上传电子检测报告24万份，自动向下游流转交易数据327万笔。  三是推进系统集成数字化。创新快检智慧集成模式，构建“一个实验室管全域、一支队伍管抽样、一张清单管项目、一个平台管运行”的“四个一”快检体系。食品安全快检追溯制度被纳入全国首个食品快检地方性法规立法。数字化追溯逐步替代传统纸质凭证索存模式，仅温州菜篮子农批市场每年就节省纸张、打印等费用20多万元。  案例二：福建省福州市“三位一体”构筑食用植物油生产监管安全防线  针对食用植物油掺杂掺假、虚标配比违法行为隐蔽，不法企业伪造、隐匿台账难以发现等问题，福州市构建数智监管、靶向治理、自律规范“三位一体”监管体系。  一是推行数智监管，构建技术防线。推动企业使用电子台账系统，系统根据产品配方与生产量自动核算原料投入量，各项数据动态关联锁定、人工无法单项修改；在调配罐前安装智能流量计，确保原料油投入量可溯源核查；在灌装线部署AI视频监控系统，自动识别生产状态并与电子台账联动预警。  二是实施靶向治理，提升监管效能。将全市食用油分装和调和油生产企业风险等级设定为D级，实施差异化监管；组建飞行检查专班，每月随机抽查一家企业；专项抽检根据产品标签真实性声明直接出具“合格”或“不合格”结论。2022年以来，对12家违法违规企业进行调查处理，2024年、2025年专项抽检监测合格率均达到100%。  三是强化自律规范，压实主体责任。推动企业在产品标签上加注真实性声称，推行原料留样制度。全市在产企业食品安全总监配备率、电子台账安装率、智能流量计配备率、产品真实性承诺率均达100%。  案例三：广西壮族自治区创新建立学校食堂食品安全信用管理“三双”体系  此前，广西壮族自治区多地试点推行学校食堂食品安全信用记分管理，但存在评价标准不一、覆盖面有限、部门协同乏力、奖惩流于形式等问题。通过创新建立“三双”体系，从根源上破解学校食堂食品安全治理难题。  一是建立“学校尽责+部门履责”双轨责任体系。明确学校校长为食品安全第一责任人，作出公开承诺；教育、人社部门督促学校落实主体责任；市场监管部门建立信用档案、开展信用评价；发展改革部门将评价结果纳入信用记录。  二是建立“风险程度+管理效能”双维指标体系。以风险记分量化信用等级，风险原始分值12分、动态扣分，信用等级由高到低分为A、B、C、D四档，同步实行四色脸谱化公示。精简形成11项扣分标准，实现从“操作违规”到“管理失职”的全链条评价。  三是建立“守信激励+失信惩戒”双向应用体系。对A级守信主体降低检查频次、无事不扰；对C、D级失信主体增加抽查比例，从严监管。将信用等级与校长职称评定、职级晋升、评优评先直接挂钩。全区已为1.45万家学校食堂建立食品安全信用档案。实施以来，获评A级食堂的学校中有38名校长获得正向激励，评级为D级食堂的学校中有10名校长被调离岗位。  案例四：辽宁省大连市完善联防联控机制，提升食品安全监管效能  大连市有300余家食品生产企业同时具备内销与出口双重属性，传统监管中市场监管部门与海关责任交叉，同一企业需分别应对两部门检查。大连市市场监管局联合大连海关，着力破解跨部门监管衔接难题。  一是厘清责任边界，搭建标准化衔接框架。联合印发《跨部门协同监管试点工作实施方案》，将两部门145项检查指标梳理为“共同责任项”“海关专属项”“市场监管专属项”三类，78项重合内容统一检查标准。建立“检查前信息互通、检查中责任共担、检查后结果互认”全流程衔接机制。  二是创新协作方式，打造高效联动机制。2020年在全国率先开展联合抽查，对大连多家企业实施“一次进门、双向履职”。建立双重属性在产企业名录库，按年度30%比例随机抽查。对海关AEO高级认证企业，市场监管部门提高信用等级、减少检查频次；对失信企业实施“双加重”协作惩戒，问题发现率较单一部门检查提高50%。  三是深化服务协作，构建赋能式协同格局。联合开展“内外贸标准对接”培训，覆盖500余家企业；针对水产制品等特色产业，组建联合专家团队制定“出口+内销”合规方案。机制实施后，企业重复迎检时间减少50%以上，制度性交易成本降低40%。  案例五：江苏省常州市创新“随手拍”共治机制，激活新就业群体护航食品安全“新引擎”  常州市面对网络餐饮点多面广、动态变化快的挑战以及传统“人海战术”式监管力量不足、发现问题滞后的情况，2025年8月，常州市市场监管局联合外卖送餐行业党委、淘宝闪购平台上线“随手拍”项目。  一是搭建全域覆盖的智慧共治平台。依托平台开发专属信息处理模块，建立“骑手发现线索—平台分类梳理—系统流转处置—监管核查反馈”数字化闭环体系，对物品摆放不整齐等轻微问题及时提醒商户自查整改，对食品安全风险隐患推送监管部门依法处置。  二是打造持证上岗的专业监督队伍。早在2022年即出台《常州市食品安全社会监督员管理办法》，推行“持证上岗”制度。从“龙城先锋骑士”、党员骑手中遴选人员颁发食品安全社会监督员聘书。建立“线上+线下”立体化培训体系，重点培训如何快速识别证照信息、后厨卫生死角等常见问题。  三是构建内外兼修的长效激励机制。实施物质与精神“双重激励”，对查证属实的线索给予现金奖励，通过工作表扬、积分兑换、平台流量倾斜等方式提升职业荣誉感。将“随手拍”监督结果纳入餐饮商户信用评价体系，对“红榜”商户给予流量扶持，对“黑榜”商户实施联合惩戒。