Delivery Method:VIA UNITED PARCEL SERVICEReference #:320-26-113Product:DrugsRecipient:Dr. Saurabh AroraManaging Director and CEOAuriga Research Pvt. Ltd.3/17 Kirti Nagar, Industrial AreaNew De(b)(4)lhi 110015IndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesAugust 12, 2026WARNING LETTERReference number: 320-26-113To Dr. Saurabh Arora:This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your contract testing laboratory. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice.FDA InspectionViolations were observed and documented during an inspection of your contract testing laboratory, Auriga Research Pvt. Ltd., FEI 3019975128, at No. 136, 6th Cross, 2nd Stage, Yeshwanthpur Industrial Suburb, Bengaluru, India, from February 4 to 6, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.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, drug products you tested 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 27, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.Violations of the Federal Food, Drug, and Cosmetic ActThe following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).Your firm is a contract testing laboratory that conducts testing of various application and nonapplication drug products for the US market. Your laboratory records lacked complete and original data demonstrating that you performed the required testing.You did not accurately complete laboratory records contemporaneously at the time you performed the laboratory activities. Our investigator observed (b)(4) microbial test samples that lacked complete documentation on raw data test sheets (e.g., the test sheets had blank spaces where entries should have been recorded). While your summary reports included final plate counts, your raw data test sheets for some of the samples covered in these reports lacked complete documentation of plate counts.In your response, you stated these samples were not from drug products intended for the U.S. market. However, your firm maintains one quality system and has one set of procedures for testing U.S. and non-U.S. drug products. Thus, the quality unit (QU) failure is applicable to all drug products you test. Additionally in your response, you identify the documentation deficiencies to be “consistent with an institutional procedural and cultural gap rather than individual misconduct or a coordinated effort to conceal or falsify results.” This indicates that these violative practices are used for all drugs you test, including those for the U.S. market.We acknowledge that your response indicated you will increase the QU presence during testing until procedural improvements, training effectiveness verification, and compliance monitoring demonstrate sustained adherence. Your response is inadequate because it does not include an assessment of your paper-based documentation system to identify and correct vulnerabilities in your current controls. Additionally, you did not provide evidence that you performed a retrospective review to identify any additional instances of incomplete or non-contemporaneous documentation.Microbial testing, an essential quality control step, is integral in preventing distribution of unsafe products. Integrity of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results or conditions associated with drug testing. Furthermore, the lack of reliable data compromises the QU’s ability to exercise its function of ensuring compliance with applicable standards.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 for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.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 comprehensive assessment of documentation systems used throughout your laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous (ALCOA) records throughout your operation.A comprehensive CAPA, overseen by a qualified consultant, for handling microbiological sampling media to ensure robust and reliable data. Establish a system that ensures uninterrupted custody and full reconciliation of all microbiological samples, including but not limited to:o unique labeling of each sampleo signatures of all staff who handle the sampleo complete tracking of sample integrity and custodyo date and time of each activity (e.g., sample collection, delivery, incubation, removal from incubator)o digital time-stamped photos of all plateso signatures of personnel performing reading of microbial countso provisions for verifications and routine quality assurance oversight.2. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit (21 CFR 211.22(d)).Your QU is inadequate as demonstrated through its oversight of investigations. Your QU reviewed and approved investigations that did not thoroughly investigate unexplained discrepancies or failures of a drug product to meet any of its specifications. For example, your QU failed to adequately ensure root causes were appropriately supported and CAPA were justified and implemented for the following:Concerning an out-of-specification (OOS) investigation for assay of (b)(4), after failing the initial test, hypothesis and two repeat tests, you changed your autotitrator instrument and reported passing results. You failed to scientifically justify the root cause, electrode sensing issue, and your investigation failed to include a CAPA.Concerning an OOS investigation for assay of (b)(4) after failing the initial test, hypothesis, and five repeat tests, you invalidated all these results. You failed to scientifically justify the root cause, which you attributed as a sample weighing error and insufficient electrode saturation. Your preventive action was inadequate as you only verbally made “concerned analysts” aware.Concerning an OOS investigation for a specified impurity, (b)(4), in stability samples, you accepted passing results by testing retain samples in triplicate. You failed to scientifically justify the root cause, which you attributed as contamination of the “MS source.” Your preventive action was inadequate as you only instructed the analyst to clean the source before the initiation of the analysis without revising your procedure.This strategy of using repeated testing until you obtain a passing result, then disregarding the OOS results without scientific justification (“testing into compliance”) is unscientific and objectionable under CGMP.In your response, you state you are revising your OOS investigation procedure to mandate your hypothesis plan with scientific justification. Your response is inadequate because you are revising procedures without performing a gap analysis of your investigations. Additionally, you have failed to address the authority, responsibility, and competency of your QU which had reviewed and approved all your out-of-specification investigations.Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/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 quality issues and to assure a continuing state of control.A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program whenever needed, ensures final quality unit decision authority, and is fully supported by executive management.A retrospective, independent review of all OOS including in-process and release/stability testing) results for U.S. products irrespective of whether the batch was ultimately distributed in the U.S. 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 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).o Provide whether customers were notified of each OOS.Responsibilities of a Contract Testing LabFDA considers contractors as extensions of the manufacturer’s own facility. Your failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs you test for your clients. It is essential that you understand your responsibility to operate in full compliance with CGMP and that you inform all your customers of any out-of-specification results or significant problems encountered during the testing of these drugs.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, 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.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.FDA may withhold approval of new applications or supplements listing your firm as a drug testing facility 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 by your clients and tested at Auriga Research Private Limited, Bengaluru, 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).Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen 15 business days of receipt of this letter1. Identify your written response with FEI 3019975128 and ATTN: Compliance Officer Barbara Wilimczyk-Macri in the letter or in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. FDA posts warning letters on www.FDA.gov.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administrationcc: RD2Rx, LLC(b)(4)_____________________________1 Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

Delivery Method:VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTEDReference #:320-26-110Product:DrugsRecipient:Wenjun LiaoGeneral ManagerTianjin Kilo Pharmaceutical Sci-tech Co., Ltd.Room 609, Building 6, no. 6 Ziyuan RoadHuayuan High-tech Industrial Park Tianjin Shi, 300384China(b)(4)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesAugust 6, 2026WARNING LETTERReference number: 320-26-110To Wenjun Liao:This warning letter advises you of significant deviations identified during a U.S. Food and Drug Administration (FDA) review of your products, processes, and records. Promptly address the deviations described herein without delay, including ensuring that appropriate resources are allocated to fully address the deviations and prevent their recurrence. This is not intended to be an all-inclusive list of the deviations that exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address deviations may result in regulatory action without further notice.FDA ReviewDeviations were identified and documented during review of your drug manufacturing facility, Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd., FDA Establishment Identifier (FEI) 3012560989. This review was conducted under FDA’s statutory authority and public health responsibilities to protect the public from drugs that are unsafe, ineffective, or of poor quality.Your facility is registered with the FDA as a manufacturer of active pharmaceutical ingredients (APIs). FDA has reviewed the records you submitted in response to our July 7, 2025 request and subsequent correspondence, for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for APIs.Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the 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 drug listing information for your drugs demecarium bromide and chlorambucil. Failure to provide listing information for a drug in accordance with section 510 of the FD&C Act, 21 U.S.C. 360, is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). As a result of this failure, these drugs are misbranded under section 502(o) of the FD&C Act, 21 U.S.C. 352(o) and their 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.Deviations from the Federal Food, Drug, and Cosmetic ActThe following are deviations identified during our review. As a reminder, this is not an all-inclusive list of deviations at your facility.1. Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.Your response to our request for records or other information pursuant to section 704(a)(4) indicates that you manufactured and distributed (b)(4) APIs to the United States (U.S.) without adequate process validation, which is critical to ensure the quality and purity of the API. For example, in response to our request on July 7, 2025, that you provide the process validation summary report for all U.S.-marketed APIs, you indicated that these APIs were still in development and were not commercial products. Therefore, formal documents such as standard operating procedures had not been finalized. However, FDA data shows that your (b)(4) APIs were distributed to 503A compounding pharmacies.Process validation evaluates the soundness of design and state of control of a process throughout its life cycle. Each significant stage of a manufacturing process must be designed appropriately and must ensure the quality of raw-material inputs, in-process materials, and finished drugs. Process-qualification studies determine whether an initial state of control has been established.Without adequate process validation, your firm lacks the basic assurance that you can reproducibly deliver products that meet specifications. See FDA’s guidance document Process Validation: General Principles and Practices at https://www.fda.gov/media/71021/download for general principles and approaches that FDA considers appropriate elements of process validation.In response to this letter, provide the following:A detailed summary of your validation program for ensuring a state of control throughout the product life cycle, along with associated procedures. Describe your program for process performance qualification (PPQ) and the ongoing monitoring of both intra-batch and inter-batch variations to ensure a continuing state of control.A timeline for performing PPQ for each of your marketed drug products.Process performance protocol(s) and written procedures for the qualification of equipment and facilities.A risk assessment and any follow-up actions to be taken for the APIs your firm produced and distributed without first performing any process-validation studies.2. Failure to prepare and use master production and control records.Your batch record for (b)(4) lacked some of the critical processing information necessary to ensure consistent manufacturing and product quality. For example, you did not list (b)(4) and major equipment used in the manufacturing process.You did not provide a batch record for (b)(4), despite being asked to provide this documentation multiple times.Without suitable batch records, you cannot adequately monitor and analyze both intra-batch and inter-batch variations to ensure that manufacturing processes remain in a state of control.In response to this letter, provide:A comprehensive, independent global review of the adequacy of the design, control, monitoring, and documentation of the production processes used for all your APIs.Appropriately detailed master batch records that capture all the significant manufacturing steps for each of your APIs.3. Failure to validate and verify the suitability of analytical methods.Based on the records and information you provided, your firm failed to perform test method validation (or verification if compendial testing is used) for each test method used for drugs distributed to the United States.Test methods must be validated to show that they are suitable for their intended use or verified to show, at a minimum, equivalence with United States Pharmacopeia (USP) compendial methods. Method validation and verification are necessary to support reliable determinations of identity, strength, quality, purity, and potency of drugs. Without evaluating the validity of methods, you lack the basic assurance that the data provided to customers were an accurate reflection of pharmaceutical product quality and safety.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 chemical and microbial test methods and specifications used to analyze each lot of your APIs before making decisions about the disposition of a lot, and the associated written procedures.4. Failure to design a documented, ongoing stability testing program to monitor the stability characteristics of APIs and to use the results to confirm the appropriate storage conditions and the retest or expiry dates.Based on the records and information you provided, your firm failed to perform routine stability testing to demonstrate that the quality attributes of your APIs remain acceptable throughout the labeled expiry period. For example, your firm did not provide stability test data for (b)(4) manufactured at your facility.Without an appropriate stability program, you lack adequate scientific evidence to support that your APIs meet established specifications and retain their quality attributes through their labeled expiry period.In response to this letter, provide:A retrospective risk assessment showing how you will ensure that your marketed APIs meet stability specifications throughout their shelf life.A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include but should not be limited to:o Stability indicating methodso Stability studies for each API in its marketed container/closure system before distribution is permittedo An ongoing program in which representative lots of each product are added to the program each year to determine if their shelf-life claim remains valido A detailed definition of the specific attributes to be tested at each station (time point)o All procedures that describe these and other elements of your remediated stability programDrug Listing ViolationsSection 510(j) of the FD&C Act and 21 CFR Part 207 set forth the requirements for the listing of drugs. Section 510(j) of the FD&C Act and 21 CFR 207.41 require registrants to list each drug they manufacture for commercial distribution. You did not provide drug listing information for demecarium bromide and chlorambucil under your own labeler code, yet you manufactured and shipped these drugs into the United States. Although these drugs are listed in FDA’s drug listing database, they are listed under a different company’s labeler code, not your own. As the manufacturer distributing these drugs into U.S. commerce, you are required to list them under your own labeler code in accordance with 21 CFR 207.41.Failure to list drugs in accordance with 510(j) of the FD&C Act, 21 U.S.C. 360(j), is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p). Furthermore, under section 502(o) a drug is misbranded if it is not included in a list required by section 510(j). Under section 301(a), the introduction or delivery for introduction into interstate commerce of any drug that is misbranded is prohibited.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.ConclusionAs previously stated, you are responsible for investigating and determining the root causes of any deviations, and for implementing corrective and preventive measures to ensure future and sustained compliance, so these violations do not recur and any others do not occur.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on July 21, 2026.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 inspect to verify that you have completed corrective actions for any deviations.Failure to address any deviations may also result in the FDA’s continuing to refuse admission of articles manufactured at Tianjin Kilo Pharmaceutical Sci-tech Co., Ltd., at Room 609, Building 6, no. 6 Ziyuan Road, Huayuan High-tech Industrial Park, Tianjin 300384, China, 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).Send your written response to CDER OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of your receipt of this letter. Identify your written response with FEI 3012560989 and ATTN: Marva Taylor in the letter or in the subject line of the email.If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.Please note that FDA posts Warning Letters on www.FDA.gov.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchFood and Drug AdministrationCc: (b)(4)

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-26-111Product:DrugsOver-the-Counter DrugsRecipient:Mr. Dipen PatelChief Executive OfficerSafrel Pharmaceuticals LLC178 Ridge RoadDayton, NJ 08810-2532United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-111August 7, 2026Dear Mr. Patel:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Safrel Pharmaceuticals LLC, FEI 3042030663, at 178 Ridge Road, Dayton, New Jersey, from January 13 to January 30, 2026.This Warning Letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21, Code of Federal Regulations, 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 February 22, 2026, response to our Form FDA 483 in detail.During our inspection, our investigators observed specific violations, including but not limited to the following:1. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality unit are not in writing and fully followed (21 CFR 211.22(a) and 21 CFR 211.22(d)).Your firm, which holds, labels1, releases, and distributes over the counter (OTC) drug products under your own label (b)(4), lacks adequate quality unit (QU) oversight and procedures for the drug products you distribute. During the inspection, you stated that no QU oversight is performed for your suppliers and contract manufacturers, including packagers. Specific failures observed during the inspection include but are not limited to the following:The absence of procedures describing how you ensure that the drug products you receive meet quality specifications, and the roles and responsibilities of each party for each of your suppliers (for example, quality agreements). Also, you do not request, receive, or maintain Certificates of Analysis (CoAs) for incoming bulk and finished OTC drug products. Notably, one of your contract manufacturers, (b)(4), has been considered noncompliant with CGMP across multiple FDA inspections.Improper segregation of drug products throughout your warehouse to prevent mix-ups. For example, boxes of finished drug products designated as “Unlabeled, No Lot, No Exp” were observed to contain unlabeled, filled product containers stored in the same general area as labeled drug products. Your firm has no written procedures describing how finished drug products are to be received, quarantined before release, stored under appropriate conditions, and approved for distribution. This is also a violation of 21 CFR 211.42.A lack of procedures by which the distribution of each lot of drug product can be readily determined, to facilitate its recall if necessary.In your response, you state that a QU was formally established, and that a quality manual and several SOPs have been created or revised.Your response is inadequate. You did not provide a comprehensive evaluation of the current state of your QU’s actual capabilities, nor did you include an assessment of the potential impact on the quality of drug products already distributed.Additionally, your response did not appear to address the systemic nature of your QU failures. While you indicate that a supplier qualification program is being implemented and that quality agreements will be executed with all suppliers, you did not provide adequate details to determine how you will ensure that incoming drug products meet appropriate quality specifications or how you will detect, monitor for, and identify CGMP noncompliance by your contract manufacturers.With respect to warehousing, your commitment to designate areas for quarantined, released, and rejected materials did not include a timeline for implementation, and you did not conduct a risk assessment for drug products currently held at or previously distributed from your facility under these conditions.Regarding traceability, while you commit to updating shipping records to include lot numbers and to creating a new distribution SOP, you did not provide sufficient detail to demonstrate that your proposed system will be capable of achieving adequate traceability (for example, lot-level).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 document Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/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 appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.A comprehensive review of your suppliers and contract manufacturers, including but not limited to:o Evaluating all suppliers and contract manufacturers to determine if they are reliable and appropriately qualified.o An assessment of all drug products to determine whether they are consistently of acceptable quality.o A review to ensure assigned expiration dates are appropriate (supported by data).o Adequacy of the supplier and contract manufacturer qualification program, and its selection, qualification, and disqualification provisions.A comprehensive review of your warehousing of drug products, including but not limited to:o Procedures relating to the receipt of drug product, quarantine before release, storage under appropriate conditions, and approval for distribution.o A list of the different types of drug products and related materials you store in your warehouse (for example, finished drug products, unlabeled drug products, expired drug products, raw materials and components) and a current inventory, including manufacturer-assigned expiration dates and status (for example, released, quarantined, rejected).A comprehensive assessment of documentation systems used throughout your manufacturing operations to determine where documentation practices are insufficient, including lot traceability from receipt through distribution.Operations Observed During the InspectionDuring the inspection, your firm stated that packaging and labeling activities conducted at the Dayton, New Jersey facility were limited to equipment functionality trials using rejected and expired materials, and that these materials were not intended for distribution. Your firm, however, was unable to provide documentation to support the disposition of the materials used in these trials. Our investigators observed the following:Multiple boxes with labels stating, “(b)(4),” and a handwritten note affixed, stating, “Needs to Change Expiry”.Multiple boxes of bottled, unlabeled drug products observed throughout the facility (for example, boxes labeled “(b)(4)”).(b)(4) boxes, each with a label stating, “(b)(4),” containing bulk tablets imprinted with “(b)(4)” on one side and “(b)(4)” on the other side.An operational packaging and labeling line with a (b)(4) product-label roll loaded onto the labeling equipment, accompanied by approximately (b)(4) boxes of corresponding bulk (b)(4) Tablets (Batch No. (b)(4), manufactured in (b)(4)), and empty plastic bottles and caps positioned in the vicinity of the line.Numerous large rolls of (b)(4)-branded drug product labels for multiple OTC drug products stored within the office area of the facility.Your firm was unable to provide documentation of your packaging and labeling operations. As a result, FDA is unable to verify the nature, scope, and disposition of materials and activities conducted at this facility.Use of Contract ManufacturersDrugs 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 are responsible for the quality of your drugs regardless of agreements in place with your contract facilities. 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.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.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 with 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 3042030663 and ATTN: Maria Pavco.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research_____________________________1 See 21 CFR 211.42 (b) regarding adequate control of labels, regardless of whether drug product labelling is conducted at your facility or sent to a contract manufacturer.

Delivery Method:VIA EMAIL NO HARD COPY TO FOLLOWProduct:Animal & VeterinaryRecipient:Markus J. DeJongOwnerDeJong Family Dairy, LLC3398 Draper RoadDorchester, WI 54425United Statesmarkus.dejong@icloud.comIssuing Office:Center for Veterinary MedicineUnited StatesWARNING LETTERCMS # 729293July 30, 2026Dear Markus J. DeJong,The U.S. Food and Drug Administration (FDA) conducted an inspection of your dairy operation, located at 102218 Draper Road, Dorchester, Wisconsin 54425 on April 6 and April 8, 2026. This letter notifies you of the significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that were found during our inspection of your operation. You can find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov. At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We received your response dated April 13, 2026, and have reviewed them below in relation to each noted violation.Adulteration of New Animal DrugsOur inspection found you did not use (b)(4) ((b)(4)) for intramammary infusion in accordance with its approved labeling and your veterinary prescription. Use of a drug in a manner that is not consistent with its labeling is extralabel use.1The manufacturer’s label for (b)(4)® states, “(b)(4)”. However, our inspection found that your treatment of multiple cows failed to conform with these directions. You administered one syringe once a day in affected quarters for three consecutive days for the following cows:Cow with ear tag (b)(4) was treated once a day with one syringe in affected quarters on August 15 through 17, 2025.Cow with ear tag (b)(4) was treated once a day with one syringe in affected quarters on August 22 through 25, 2025.Cow with ear tag (b)(4) was treated once a day with one syringe in affected quarters on January 11 through 13, 2026.Since you did not follow the labeled directions, you used the drug in an extralabel manner. The extralabel use of approved animal or human drugs is only allowed if the extralabel use complies with the FD&C Act, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian-client-patient relationship,2 and 21 CFR 530.3 Your extralabel use of this drug was not done in accordance with an order from a licensed veterinarian, in violation of 21 CFR 530.11(a). Because your extralabel use of this drug was not in compliance with the FD&C Act and 21 CFR 530, you caused the drugs to be unsafe and adulterated.4 The doing of any act to a food or drug after shipment of the food or drug and/or its components in interstate commerce and while the food or drug is held for sale (whether or not the first sale) that results in the food or drug being adulterated or misbranded is a prohibited act.5Evaluation of your response:We reviewed your emailed response dated April 13, 2026. Your response does not provide enough details for us to adequately evaluate the effectiveness and sustainability of your actions. You did not provide supporting documentation that you trained your employees in the proper use of the medications they administer to your animals. You also did not provide supporting documentation, such as treatment records, demonstrating the correct use of (b)(4) and other drugs at your dairy.ConclusionThis letter is not intended to be an all-inclusive statement of violations that may 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. It is your responsibility to ensure that you comply with all requirements of federal law and FDA regulations.This letter notifies you of our concerns and provides you with an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address any violation may lead to regulatory, or where appropriate, legal action.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.The Food & Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance is encouraging electronic submission of any response you choose to submit to this letter. We encourage you to submit files up to 100 megabytes in a single email, and to divide files greater than 100 megabytes so they may be submitted as smaller files in separate emails. If you submit electronic correspondence, please ensure that your facility’s name, the CMS number at the top of this letter, and the inspection location are included in your correspondence. We intend to issue an electronic acknowledgement upon receipt of your email.Please direct your electronic correspondence to Compliance Officer Stephen J. Rabe at Stephen.rabe@fda.hhs.gov. If you have questions regarding this letter, please contact Compliance Officer Stephen J. Rabe by email or telephone at 513-322-0660./S/Isaac K. CarneyDirector of Food Compliance, Office of Surveillance and ComplianceCenter for Veterinary MedicineU.S. Food and Drug AdministrationCC:Janet McGinn, DirectorDivision of Dairy SafetyOffice of Dairy and Seafood SafetyHuman Food ProgramJanet.mcginn@fda.hhs.gov______________________1 See 21 CFR 530.3(a).2 See 21 CFR 530.3(i).3 See section 512(a)(4) and Section 512(a)(5) of the FD&C Act [21 U.S.C. §§ 360b(a)(4) and 360b(a)(5)].4 Under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)], a new animal drug is deemed adulterated if it is unsafe within the meaning of section 512 of the FD&C Act [21 U.S.C. § 360b].5 See Section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].

各盟市药品检验检测机构，各药品生产企业、医疗机构制剂室、药品第三方检验检测实验室：为持续提升自治区药品检验检测能力和质量保证水平，确保检验检测结果的准确、可靠，自治区药监局决定组织开展2026年药品实验室间比对活动。现将有关事项通知如下。一、参加范围自治区内具备相应实验条件的药品相关检验检测机构、药品生产企业、医疗机构制剂室、药品第三方检验检测实验室。二、具体内容盐酸倍他司汀的含量测定（可选非水溶液滴定法或高效液相色谱法参加）。三、报名方式（一）报名截止日期：2026年8月25日。（二）各单位按照《2026年内蒙古自治区药品实验室间比对报名表》（附件1）填报信息，加盖单位公章扫描后，扫附件2的二维码提交上传。四、有关要求及注意事项（一）各参加单位可根据本实验室成熟的方法选择本次实验室间比对项目的检测方法。（二）各参加单位应正确认识实验室间比对活动的本质、目的和意义，将其作为常规质量保证手段，客观真实反映自身的检验能力和质量保证水平，确保参加实验室间比对活动取得实效。（三）各参加单位应充分利用实验室间比对结果，发现和改进存在的问题，切实提高检验检测能力水平。（四）各参加单位准确填写报名表信息，作业指导书将通过报名联系人电子邮箱发送，比对样品将按报名表填报的单位收件地址邮寄，请报名联系人注意查收。2026年自治区药品实验室间比对活动由自治区药品检验研究院承办。本次实验室间比对活动不收取任何费用，比对结果将在适当范围公布。联系人：葛丽萍联系电话：0471－4503273  13947183570联系人：杨永峰联系电话：0471－4318189附件：1.2026年内蒙古自治区药品实验室间比对活动报名表 2.报名二维码内蒙古自治区药品监督管理局2026年8月17日

根据《中华人民共和国药品管理法》及国家市场监督管理总局《药品生产监督管理办法》等相关规定，经我局按程序进行现场检查和审核批准，拟向吉林恒睿医药科技有限公司、吉林凯莱英制药有限公司核发《药品生产许可证》，现予以公示，公示期为5个工作日，请社会各界予以监督。监督电话：0431-82752007通讯地址：长春市人民大街9999号邮政编码：130000特此公告附件：拟核发《药品生产许可证》的企业名单（2026年第5期）吉林省药品监督管理局2026年8月17日附件：拟核发《药品生产许可证》的企业名单（2026年第5期）企业名称注册地址社会信用代码法定代表人企业负责人质量负责人生产负责人质量受权人生产地址和生产范围吉林恒睿医药科技有限公司长春市净月开发区小合台工业区9号地银锦路558号201号房91220103MAC1XXWL5Y金建志金建志杨莹郝秀平杨莹长春市净月开发区小合台工业区9号地银锦路558号201号房：中药饮片（净制、切制）***吉林凯莱英制药有限公司吉林省延边州敦化市高新产业园区兴企路599号91222403MA14U80M8Y范艳武范艳武杨明旸罗勇杨明旸吉林省延边州敦化市高新产业园区兴企路599号：原料药（氢溴酸替比培南）（仅用于出口）

根据《中华人民共和国行政许可法》第七十条、《市场监督管理行政许可程序暂行规定》第四十八条和第七十八条、《药品经营和使用质量监督管理办法》第二十七条的规定，安徽省药品监督管理局依法注销合肥赛瑞康致医药有限公司《药品经营许可证》（详细信息见附件）。特此公告。附件：注销《药品经营许可证》清单                               安徽省药品监督管理局                                 2026年8月14日注销《药品经营许可证》清单注销企业名称许可证号经营地址备注合肥赛瑞康致医药有限公司皖AA551000532安徽省合肥市蜀山区蜀峰路558号融智大厦1406、1407室企业申请注销

按照《中华人民共和国药品管理法》《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等相关规定，根据臻儒医药（河南）有限公司申请，现注销臻儒医药（河南）有限公司的《药品经营许可证》（证书编号：豫AA395000245）。特此公告。附件：臻儒医药（河南）有限公司《药品经营许可证》有关信息表2026年8月10日附件臻儒医药（河南）有限公司《药品经营许可证》（批发）有关信息表企业名称法定代表人（负责人）主要负责人质量负责人经营方式经营范围经营地址仓库地址证书编号臻儒医药（河南）有限公司叶桂园付素娜赵小芳批发中药饮片、中成药（含冷藏药品）、化学药（含冷藏药品）生物制品（含冷藏药品）、蛋白同化制剂、肽类激素（含冷藏药品）河南省漯河市源汇区湘江西路豫中南速递电商物流产业园二楼231室河南省漯河市源汇区干河陈小村铺村美的（漯河）分销中心4#分销仓库《药品经营许可证》（证号：豫AA395000245）

南昌市朝阳医疗保健用品有限公司报告，由于本次召回涉及我公司生产车间变更。在该变更事项尚未取得监管部门批准的情况下，我公司即擅自组织生产。鉴于该行为已违反相关法规要求，并可能对产品安全、有效性和质量可控性带来潜在风险，为履行企业主体责任，我公等原因，南昌市朝阳医疗保健用品有限公司对其生产的一次性使用手术单(注册备案号:赣械注准20182140142)主动召回，召回级别为三级,涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表.pdf2026年8月17日

广西太华药业有限公司华祥大药房于2026年8月13日向我局提交了关于注销《互联网药品信息服务资格证书》的申请。根据《互联网药品信息服务管理办法》及《国家药监局关于发布互联网药品医疗器械信息服务备案管理规定的公告》（国家药品监督管理局公告2025年第123号）的相关规定，我局同意注销广西太华药业有限公司华祥大药房《互联网药品信息服务资格证书》。附件：注销《互联网药品信息服务资格证书》企业名单广西壮族自治区药品监督管理局2026年8月17日