Delivery Method:Via EmailProduct:DrugsRecipient:Martin PytelaPresidentLife Enthusiast Co-op711 S Carson Street Suite 4Carson City,NV89701United Statessupport@life-enthusiast.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERAugust 25, 2025RE: 709315Dear Martin Pytela:This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.life-enthusiast.com/ in May 2025. The FDA has observed that your website offers “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” for sale in the United States. Based on our review, these products are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).Your “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” products are especially concerning from a public health perspective. Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.You appear to be marketing your “MSM Gold Drops” as a dietary supplement. The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Your “MSM Gold Drops” is intended for topical use. Therefore, your “MSM Gold Drops” product does not meet the definition of a dietary supplement under the FD&C Act.Based on a review of your website, your “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), 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 of claims from your websites that provide evidence of the intended use of these products as drugs include, but may not be limited to, the following:Amazing CollyrioOn the webpage https://www.life-enthusiast.com/shop/ww4112-amazing-colyrio-2190?category=125#attr=121:“Alleviates Eye Irritations”“Relieves Tired, Strained Eyes”“Amazing Colyrio helps provide adequate oxygen to eye tissues. And helps restore the electrolyte balance of natural tears.”“Helps alleviate high pressure and pain. Provides a moisturizing and soothing effect within minutes.”Fulvic EyesOn the webpage https://www.life-enthusiast.com/shop/emgfe-fulvic-eyes-3181?category=125#attr=2576:“STOPS RED EYES[,] ELIMINATES DRY EYES[,] RESTORES VISION”“This potent formula works to:o Aid cellular refreshment. . ..o Support efficient nutrient delivery to delicate eye structures. . ..o Assist the eyes in maintaining a healthy, comfortable state.”“Unique ingredient for gentle support. . ..o Promotes visual clarity.o Helps soothe and refresh dry-feeling eyes.”“Can be used topically in eyes, nose, ears, throat or other body parts to soothe irritation.”MSM Gold DropsOn the webpage https://www.life-enthusiast.com/shop/emsmg-msm-gold-drops-3261?category=125#attr=2461:“MSM Gold Dropso Ease Irritations and Infections. [sic] in Eyes, Ears, Sinuses and Skino Helps Relieve Eye Strain from Screens and Drivingo Soothe Sensitive, Itchy Eyes”“Safe for topical use (on your skin) in your eyes, nose and ears. Consider using after removing your contact lenses.”“Supports Joint Comfort[,] Enhances Mobility[,] Aids Connective Tissue Health”“The silver and gold help fight infections. Zinc and copper speed repairs. Hyaluronic Acid builds flexibility”“Helps maintain comfortable movement and ease in your joints”Your “Amazing Colyrio,” “Fulvic Eyes,” and “MSM Gold Drops” are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). 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). There are no FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).The violations cited in this letter are 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.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps 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 believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “709315” in the subject line of the email.Sincerely,/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 Administration

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-25-103Product:DrugsRecipient:Mr. Heath AshenfelterPresident and CEOWisconsin Pharmacal Company, LLC1 Pharmacal WayJackson,WI53037United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-103August 22, 2025Dear Mr. Ashenfelter:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Wisconsin Pharmacal Company, LLC, FEI 2124143, at N168 W 22223 Main St., Jackson, WI, from March 3 to 7, 2025.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).We reviewed your March 27, 2025, 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’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).Your quality unit (QU) did not provide adequate oversight for the manufacture and release of your over-the-counter (OTC) drug products. For example, you filled batch(b)(4)of your(b)(4)Spray from vessels(b)(4). Your QU rejected the drug product units filled from vessel(b)(4)because they failed assay test release specification for(b)(4). You attributed insufficient(b)(4)of the corresponding batch in vessel(b)(4)as the root cause. However, you released drug product filled from vessels(b)(4).In addition, your QU failed to exercise its responsibility by not withholding from distribution all rejected units filled from vessel(b)(4)and instead allowing the distribution of approximately half of the rejected drug product. Your practice of rejecting a partial drug product batch is an indication that your firm does not have well-controlled manufacturing and release procedures.In your response, you acknowledge that the rejected drug product was not adequately identified and contained due to improper scanning procedure. You took a corrective action that included revising your procedure for non-conforming and rejected materials and retraining your staff.Your response is inadequate because you do not provide details on how your corrections and corrective actions will prevent recurrences of distributing rejected drug products to customers. You fail to address the fundamental deficiencies in your QU that led to these failures. You do not provide a comprehensive corrective action and preventive action (CAPA) plan with a systematic approach to correct these oversight deficiencies.Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor 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/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.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:• A determination of whether all procedures used by your firm are robust and appropriate.• A retrospective review of testing results for all released drug products. If failures are identified, take rapid corrective actions, such as notifying customers and drug product recalls.• Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.• A complete and final review of each batch and its related information before the QU disposition decision.• Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all drug products.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).You failed to adequately investigate multiple microbial excursions reported for objectionable microorganisms found during testing of your OTC drug products. For example, objectionable microorganismStaphylococcus aureus (S. aureus)was identified during drug product batch testing, including but not limited to:• On November 11, 2024, objectionable microorganismS. aureuswas found in your(b)(4)Cream, batch(b)(4). You released the referenced batch for commercial distribution based on a passing retest result obtained without conducting a thorough investigation into the root cause of the contamination.Without a comprehensive investigation into your manufacturing process and supporting data, you claimed the root cause of the contamination of the(b)(4)Cream batch was due to microbial testing and thatS. aureusis commonly found on human skin. You concluded there was no evidence to suggest batch contamination because no growth was detected during repeat testing of the original tube and retain samples.• On August 19, 2024, objectionable microorganismS. aureuswas found in your(b)(4), batch(b)(4). After retesting, you rejected drug products filled from the(b)(4)impacted vessels. You did not conduct a thorough investigation to determine the root cause of the contamination, and you released drug product units filled from the remaining(b)(4)other vessels based on passing retest results.Your determination regarding the scope of the microbial contamination is flawed. Microbial contamination may not be uniformly distributed, and passing sample results obtained from units filled from one vessel or container may not be indicative of results from other portions of a batch. As a manufacturer, you have a responsibility to fully investigate microbial contamination results that may impact drug product quality.In your response, you acknowledge that you failed to perform a holistic investigation into the root cause of the microbial contamination by including a review of data from environmental monitoring, cleaning, and sanitization as part of the investigation. You also acknowledge that you incorrectly relied on the retest data without adequately investigating the contamination source prior to retesting. You commit to immediately begin additional sanitizations and cleaning until the root cause of contamination is identified. You also commit to creating and revising procedures for routine equipment surface monitoring and providing a detailed investigation process for microbial contamination.Your response is inadequate because you fail to provide a comprehensive assessment of microbial contamination in your OTC drug products, including but not limited to, a review of elements of your operation that may introduce bioburden or permit microbial proliferation. Your response lacks a comprehensive drug product impact assessment.In response to this letter, provide:• A comprehensive independent assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification 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 assurance oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.o Include your updated investigation procedures and a clear description of how investigations are initiated, documented, and completed.• A comprehensive independent assessment of the design and control of your firm’s manufacturing operations, with a detailed and thorough review of all microbiological hazards. Also address the hazards posed by distributing drug products that are objectionably contaminated. Specify actions you will take in response to the risk assessment, such as customer notifications and drug product recalls.• A summary of all results obtained from testing retain samples from each batch of the(b)(4)drug product.• A list of all investigations into all batches with potential objectionable microbial contamination, including but not limited to, any out-of-specification (OOS) result, whether or not later invalidated. Include a copy of the complete investigations that detail your findings regarding the root causes of the contamination and any CAPA that were identified.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 (21 CFR 211.68(b)).Your firm lacked sufficient controls over your liquid chromatography (LC) and gas chromatography (GC) instrument used to test drug products prior to release. Specifically, your firm did not appropriately control administrative privileges for file modification and deletion using your Agilent OpenLab software data system.During the review of analytical system audit trails for final release testing of finished OTC drug products, our inspection found that your firm does not review audit trails and raw analytical data captured by these analytical instruments. You do not have written procedures to review electronic data or integration to ensure data reliability for batch release.Your quality system does not adequately ensure the adequacy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. Without complete and accurate records, you cannot assure appropriate decisions regarding batch release, drug product stability, and other matters that are fundamental to ongoing assurance of quality.Your response acknowledges that your firm failed to appropriately set up the instrumentation software used for data collection and analysis of OTC drug products. You also acknowledge that your firm failed to review audit trails and establish an SOP requiring review of computer-generated data during batch release testing. You commit to taking corrective actions, including updating user access and permissions for all lab instruments and creating a new SOP requiring review of raw data and audit trails prior to batch release.Your response is inadequate because it lacks an independent review including, but not limited to, an assessment of drug product impact and whether a retrospective review is warranted based on the drug product impact assessment. Your response also did not provide adequate details of management oversight to ensure effectiveness of the corrective actions implemented.In response to this letter, provide:• A comprehensive, independent assessment of computer system performance and security. Provide a report that identifies vulnerabilities in the design and controls, and a thorough corrective action and preventive action (CAPA) plan for each of your laboratory computer systems, which addresses the following elements:o A list of all hardware (both standalone and networked) and software used by your laboratory.o Identify and evaluate 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 Detail the associated user privileges for each system. Specify user roles and associated user privileges for all staff levels who have access to the laboratory computer system, and provide organizational affiliations, responsibilities, and titles. Clearly specify all staff who have administrator privileges. Fully describe how you will ensure segregation of firm personnel involved with laboratory testing from those with administrator rights. For all staff roles that are permitted to have administrative rights, specify the scope and type of privileges.o Assess each system to determine if unique usernames and passwords are used.o Evaluate 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.o Provide requirements for data retention and backup for all laboratory systems.o Describe how you will ensure that all quality control tests are performed by an analyst and receive second-tier review from a separate qualified individual (e.g., lab manager). Provide related procedure(s).o Summarize your interim controls to assure reliable performance and security while your CAPA plan is being implemented.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.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 address this matter promptly and adequately 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 2124143 and ATTN: Joan Johnson.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA Electronic MailReference #:320-25-104Product:DrugsRecipient:Mr. Chintu PatelCo-Chief Executive OfficerAmneal Pharmaceuticals, LLC50 Horseblock RoadBrookhaven,NY11719-9509United Stateschintu@amneal.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-104August 27, 2025Dear Mr. Patel:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Amneal Pharmaceuticals Private Limited, FEI 3018907202, located at 506 Survey No., near Sachana Kalyanpura Road Palli, Gujarat, India, from March 10 to 19, 2025.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).We reviewed your April 3, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondences.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. 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 conduct an adequate investigation into recurring problems with visible particulate matter contamination. In 2024, your firm initiated an investigation when two batches of ropivacaine hydrochloride injection, supplied in polypropylene bags, exceeded your acceptance criteria for visual inspection. You identified the polypropylene bags as the source of the inordinately high levels of particulate contamination (predominately, white fibers). You performed an additional visual inspection and conducted a risk assessment that you believed justified releasing these batches. However, your risk assessment was inadequate as it minimized the severity associated with particle contamination in a sterile injectable drug product that can be administered into the epidural space. Your assessment failed to properly evaluate the potential impact of visible particulates on patient safety, as it did not adequately consider the route of administration and patient population receiving the product.The presence of particulate matter in epidural injectable products can pose significant health risks to patients. These risks are of particular concern for patients receiving long-term epidural therapy. There is a reasonable probability that particulate matter in the epidural space may cause an epidural inflammatory process, epidural abscess, or meningitis. Depending on the location of the epidural injection, the particles could potentially cause damage to the spinal cord including spinal cord infarction or permanent nerve injury.Your firm was aware of the risk of particulate contamination from the polypropylene bags purchased from your vendor for more than a year prior to your 2024 investigation. You had rejected several batches of a sterile drug product after investigating particulate contamination in late 2022 and early 2023. Your investigations found that the polypropylene bags were the source of the visible white fibers and noted difficulties in detecting these fibers when performing visual inspection. Notably, for multiple batches, your firm continued to detect visible fiber particles during acceptable quality limit inspections of limited sample sizes following performance of visual inspections.However, you continued to use these polypropylene bags to produce sterile injectable drug products and did not implement appropriate corrective action and preventive action (CAPA) to prevent recurrence.Based on your investigations into particulate contamination, you relaxed the “major defects” rate from no more than (NMT)(b)(4)% to NMT(b)(4)%, and the overall rejection limit from NMT(b)(4)% to NMT(b)(4)%. You implemented these significantly relaxed limits due to the high rate of particulate contamination in polypropylene bag lots received from your unreliable vendor. The inappropriately high tolerance for defective polypropylene bags accommodated the use of poor-quality polypropylene bags in the production of parenteral drug product batches.It is unacceptable to increase lot acceptance specifications to excessive levels to enable use of unsuitable polypropylene bags received from your supplier.In your response, you indicate that, on March 26, 2025, you filed a Field Alert Report for two lots of ropivacaine hydrochloride injection, USP, 500 mg/100 mL infusion bags due to particulate contamination. You also initiated a recall of these two lots on April 18, 2025. The company announcement was posted to the FDA website: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-ropivacaine-hydrochloride-injection-usp. However, these actions were initiated only after FDA identified these problems during the current inspection.You also indicate that you will be revising your major defect and total defect limits for polypropylene bag visual inspection from NMT(b)(4)% to NMT(b)(4)%, and NMT(b)(4)% to NMT(b)(4)%, respectively, and will reject batches that fail to meet your acceptable quality limit after visual inspection. These defect levels remain unacceptably high.Furthermore, the health hazard assessment included in your response minimized the severity of risks associated with particle contamination in a sterile injectable drug product that can be administered into the epidural space.We encourage the use of suitable(b)(4)visual inspection methods for particulates to augment the 100%(b)(4)visual inspection program.(b)(4)methods should be rigorously studied and qualified to assess their capability and robustness under various conditions, including machine settings, container-closure sizes, defect types, product characteristics, and other variables. In addition, any use of(b)(4)particulate inspection as an adjunct method does not supplant the need for 100%(b)(4)visual inspection. It is essential that a final visual inspection program ensures reliable detection of not only particulates, but various other defects (e.g., container or closure abnormalities, cracks, volume, crimping issues, atypical(b)(4), discoloration, bubbles, and any other appearance defects).It is important that significant quality defects, including visible particulate contamination, are appropriately evaluated and investigated. Visible particulates in injectable products should be avoided through appropriate preventive measures built into your process design and production controls.In response to this letter, provide:A comprehensive assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification 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 (QU) oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.A comprehensive, independent review of your materials system, including but not limited to:o An evaluation of all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified.o An assessment of all materials to determine whether they are consistently of acceptable quality.o A review to ensure assigned expiration or retest dates are appropriate (supported by data).o An assessment of the adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions.Based on a thorough review, provide a summary of your systemic CAPA to remediate the vendor qualification program and prevent use of unsuitable components, containers, and closures.A commitment to have a third-party review your firm’s defect categorization pertaining to the visual inspection program, including defining critical, major, and minor defects.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.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.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.Identification of interim steps and controls to ensure lots being produced and distributed into U.S. commerce are essentially free of visible particulate matter.Revision of your risk assessment procedures to ensure thorough evaluation of potential patient impact, and address factors including but not limited to route of administration, patient population, and particle characteristics.Training for all relevant personnel on revised policies, procedures, and other associated items.2. 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)).During our inspection, we observed the preparation and reading of bacterial endotoxin tests and identified numerous deficiencies:Failure to completely discharge the micropipette solution during preparation of water for injection samples, which may compromise the accuracy and reproducibility of the test results.Transfer of gel-clot sample tubes from the incubator to the waste container in a single rapid motion during microbiological analysis, without the crucial pause required to inspect the firmness of the gel for endotoxin detection.The analyst responsible for the(b)(4)verification of the gel-clot assessment was unable to adequately observe or verify the process due to the primary microbiologist’s rapid assessment. Despite this basic deficiency, the secondary analyst signed off on the verification.Inadequate documentation practices when recording sample results of bacterial endotoxin tests for water for injection, including non-contemporaneous documenting of negative sample results and assigning a passing result to a positive control sample prior to the actual observation and confirmation of the result.In your response, you state that you revised various procedures, provided associated training, retested reserve samples of potentially impacted drug products, and purchased new equipment to increase laboratory automation.Your response is inadequate due to its limited scope, which primarily addressed the specific deficiencies identified during the FDA inspection. You did not conduct a comprehensive evaluation to determine if similar deficiencies exist in other laboratory operations or address additional opportunities for laboratory equipment automation.It is imperative that your organization conducts a more thorough and systemic review of all laboratory processes, testing methodologies, equipment capabilities, and documentation practices to ensure compliance with CGMP and prevent recurrence of similar issues in the future.In response to this letter, provide:A comprehensive 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 complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.Quality Unit AuthoritySignificant findings in this letter indicate that your QU is not fully exercising its authority and/or responsibilities. Your firm must provide the QU with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.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.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.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 Amneal Pharmaceuticals Private Limited, FEI 3018907202, located at 506 Survey No., near Sachana Kalyanpura Road Palli, Gujarat, 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.1Specify 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 3018907202 and ATTN: CDR Frank Verni, Compliance Officer.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Researchcc:Mr. Sandeep Raktate, President (Operations)Sandeep.Rakate@amneal.com_______________1Under 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.

行政相对人名称安徽贵皖药业有限责任公司行政相对人类别法人及非法人组织统一社会信用代码913416003487151117法定代表人姜祥民行政处罚决定书文号皖药监药处罚﹝2025﹞2-30号处罚类别罚款;没收违法所得;没收非法财物处罚决定日期2025-09-02处罚内容1.没收劣药浙贝母183.4kg；2.没收违法所得1640.00元；3.处罚款计410000.00元。罚款金额（万元）41.000000没收违法所得、没收非法财物的金额（万元）2.835000暂扣或吊销证照名称及编号违法行为类型违反了《中华人民共和国药品管理法》（2019年修订）第九十八条第一款、第三款违法事实生产销售劣药浙贝母处罚依据《中华人民共和国药品管理法》（2019年修订）第一百一十七条第一款处罚机关安徽省药品监督管理局处罚机关统一社会信用代码11340000MB19570665数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665状态

行政相对人名称安徽特仑沙克生物科技研究有限公司行政相对人类别法人及非法人组织统一社会信用代码91340102MA2RRWYE0Y法定代表人郑前进行政处罚决定书文号皖药监妆处罚﹝2025﹞1-16号处罚类别罚款;没收违法所得处罚决定日期2025-09-02处罚内容1.没收违法所得人民币陆佰柒拾贰元整；2.罚款:人民币壹万元整。罚没款合计壹万零陆佰柒拾贰元整。罚款金额（万元）1.000000没收违法所得、没收非法财物的金额（万元）0.067200暂扣或吊销证照名称及编号违法行为类型《化妆品监督管理条例》第二十九条第一款、第三十一条第二款违法事实当事人生产化妆品未经检验合格即上市销售的行为，违反《化妆品生产质量管理规范》第四十五条第一款“企业应当建立并执行产品放行管理制度，确保产品经检验合格且相关生产和质量活动记录经审核批准后，方可放行”的规定，该条款内容为《化妆品生产质量管理规范检查要点及判定原则》中关键项目（74**），应当判定为“生产质量管理体系存在严重缺陷”。处罚依据《化妆品监督管理条例》第六十条第一款第（三）项处罚机关安徽省药品监督管理局处罚机关统一社会信用代码11340000MB19570665数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665状态

序 号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监武药处罚〔2025〕16号武汉奇运佳大药房连锁有限公司杜全91420105MA4F2RA81Y销售劣药当事人销售劣药托西酸舒他西林胶囊(批号：2406801)的行为，违反了《中华人民共和国药品管理法》第九十八条第一款的规定没收违法所得《中华人民共和国药品管理法实施条例》第七十五条的规定主动履行2025年8月25日湖北省药品监督管理局2025年8月25日

经监督检查，揭阳市泰睿药业连锁有限公司等2家药品经营企业的综合评定结论为不符合要求，存在药品质量安全隐患。根据《药品管理法》第九十九条及《药品检查管理办法（试行）》第六十一条规定，广东省药品监督管理局对揭阳市泰睿药业连锁有限公司等2家药品经营企业采取暂停销售（配送）风险控制措施，现予以公布。序号企业名称药品经营许可证编号综合评定结论风险控制措施1揭阳市泰睿药业连锁有限公司粤BA663000746不符合要求暂停销售(配送)2深圳市健华药业连锁有限公司粤BA755000067不符合要求暂停销售(配送)　　企业应当严格落实主体责任，按照检查处理结果要求暂停销售（配送），排除质量安全隐患后，向广东省药品监督管理局提交整改报告，经复查符合条件后予以解除风险控制措施。　　特此通告。广东省药品监督管理局2025年9月1日

近日，江西省药监局正式印发《江西省药品经营仓储运输管理办法（试行）》（以下简称《办法》），从异地设库、多仓协同、委托储运、信息系统建设、企业主体责任和监管要求等六个方面统一规范药品经营企业异地设库、多仓协同和委托储存配送活动，支持企业有效整合仓储资源和运输资源，进一步推动药品流通行业规模化、集约化、现代化发展。《办法》支持具备江西省药品现代物流条件的企业在具备统一的药品质量管理体系、计算机信息管理系统和实现药品全品种追溯管理的前提下，申请开展异地设库、多仓协同和委托储存配送，全面降低物流成本。开展异地设库、多仓协同、委托储存配送的企业应按照《药品经营和使用质量监督管理办法》，向江西省药监局提出申请，并按《药品经营许可证》变更仓库地址事项程序办理。《办法》明确了企业主体责任。开展多仓协同活动的企业，由主体方承担药品多仓协同的主要责任，协同方承担药品储存运输过程中的质量管理责任。开展药品委托储存配送的企业，由委托方承担药品经营的主体责任，受托方承担药品储存运输过程中的质量管理责任。对有证据证明可能存在安全隐患的企业，药品监督管理部门根据监督检查情况，采取告诫、约谈、限期整改以及暂停异地设库、多仓协同、委托储存配送等措施；对拒不整改、整改不合格、伪造温湿度监测数据及药品追溯数据或者存在重大质量风险隐患的企业，终止其异地设库、多仓协同、委托储存配送相关资质；对存在违法行为的企业，依法依规进行处理。（省药监局药品经营处供稿）

根据《中华人民共和国行政许可法》《中华人民共和国药品管理法》《药品经营和使用质量监督管理办法》等规定，现决定依法注销江西天之源药业有限公司、江西帝承医药有限公司、江西益轩医药有限公司、江西五洲康连锁大药房有限公司的《药品经营许可证》（详见附件）。特此公告。附件：注销药品经营许可证企业名单 江西省药品监督管理局 2025年9月2日附件注销药品经营许可证企业名单序号企业名称法定代表人许可证编号注册地址注销原因1江西天之源药业有限公司郭小香赣AA7960468江西省吉安市峡江县工业园区创新创业孵化园5栋厂房主动申请注销2江西帝承医药有限公司范春如赣AA796000490江西省吉安市新干县城北工业园区江洲路2号主动申请注销3江西益轩医药有限公司范春如赣AA796000452江西省吉安市新干县河西工业园工业五路一号主动申请注销4江西五洲康连锁大药房有限公司张念兵赣BA7920041江西省九江市经开区长城路121号恒盛科技园18号楼302室主动申请注销

经查，江西星亚医药有限公司监督检查综合评定结论为不符合要求。鉴于该公司经营存在药品质量安全隐患，依据《中华人民共和国药品管理法》第九十九条第三款、《药品经营和使用质量监督管理办法》第六十三条、《药品检查管理办法（试行）》第六十二条等规定，决定自公告之日起对该公司采取暂停药品销售的风险控制措施，该公司停业期间不得擅自开展药品经营活动，现予以公告。附件：江西星亚医药有限公司经营地址等情况 江西省药品监督管理局 2025年9月2日附件江西星亚医药有限公司经营地址等情况序号企业名称经营地址仓库地址经营范围许可证编号1江西星亚医药有限公司江西省赣州市章贡区章贡高新区沙河口路16号综合楼二楼203室江西省赣州市章贡区章贡经济开发区天龙山路22号1号厂房（南华医药赣州有限公司）中药饮片；中成药；化学原料药；化学药制剂；抗生素原料药；抗生素制剂；生化药品（冷藏、冷冻药品除外）赣AA7970372