序号行政处罚决定书文号案件名称违法企业名称或违法自然人姓名违法企业组织机构代码法定代表人姓名主要违法事实行政处罚的种类和依据行政处罚的履行方式和期限做出处罚的机关名称和日期备注1桂药监玉分生罚〔2026〕1号广西草本源中药饮片有限公司生产劣药柴胡（北柴胡）案广西草本源中药饮片有限公司91450900MA5KCED353陈小凤生产劣药柴胡（北柴胡）没收违法所得、没收非法财物、罚款，《中华人民共和国行政处罚法》第二十八条，《中华人民共和国药品管理法》第一百一十七条第一款未履行广西壮族自治区药品监督管理局，11450000MB151972XY相关附件：桂药监玉分生罚〔2026〕1号.pdf

四会市瑞华药房店：　　经调查，你公司长期未开展经营活动，已不在注册地址经营，且无法联系企业，已不具备经营药品的基本条件。综上所述，我局依据《广东省食品药品监督管理局关于

案件名称辽宁健昌医药连锁有限责任公司销售劣药清气化痰丸案处罚决定文书号辽药监(稽十四)罚〔2026〕1号被处罚企业名称辽宁健昌医药连锁有限责任公司统一社会信用代码91211422MA0Y9PEP9H法定代表人谷莉莉主要违法事实当事人销售劣药清气化痰丸，但其进货渠道合法，提供的供货单位许可文件、产品合格证明、销售票据等真实合法；产品采购与收货记录、入库检查验收记录真实完整；产品的储存、养护、销售、使用、出库复核、运输按照有关规定执行且有真实完整的记录。有充分证据证明不知道所销售或者使用的药品是劣药。行政处罚种类和依据没收违法所得； 依据《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国药品管理法实施条例》第七十五条。处罚结果没收违法所得783.83元。行政处罚履行方式和期限主动履行；当事人已于2026年1月30日履行完毕。作出处罚的日期2026-01-27

按照《山东省药品经营企业长期停业和恢复经营监督管理规定》（鲁药监规〔2023〕8号），国药控股浩源（平度）医药有限公司等3家药品经营企业在《药品经营许可证》有效期内申请停业。停业期间，企业承诺不开展药品经营活动。企业在《药品经营许可证》有效期内恢复药品经营，需向药监部门提交书面报告，并经检查符合要求后方可恢复经营活动。现予以公告。附件：长期停业药品经营企业（单位）名单山东省药品监督管理局2026年2月6日

根据《中华人民共和国行政许可法》第七十条、《化妆品生产经营监督管理办法》第二十三条的规定，安徽省药品监督管理局依法注销中健泰克生物科技有限公司《化妆品生产许可证》（详细信息见附件）。特此公告。附件：注销《化妆品生产许可证》清单安徽省药品监督管理局                                                 2026年2月9日   附件注销《化妆品生产许可证》清单企业名称许可证编号生产地址备注中健泰克生物科技有限公司皖妆20210003马鞍山经济技术开发区太白大道2150号富马智速科技园3栋第一层有效期届满未申请延续

 近期，天津市药监局组织对天津芭薇生物科技有限公司等5家化妆品生产企业进行了飞行检查，现通告检查结果。为保障公众用妆安全，天津市药监局要求属地监管部门监督企业进行整改。具体情况见附件。特此通告。附件：1.天津芭薇生物科技有限公司飞行检查结果2.天津尚美化妆品有限公司行检查结果3.天津妈哈哈生物技术有限公司飞行检查结果4.天津盛世永业科技发展有限公司飞行检查结果5.天津奥莉天然化妆品有限公司飞行检查结果                       2026年1月27日（此件主动公开）   

Delivery Method:VIA Electronic MailProduct:DrugsRecipient:John HowellExecutive Vice PresidentBoothwyn Pharmacy, LLC221 Gale LaneKennett Square,PA19348United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 717525January 16, 2026Dear Mr. Howell:From May 12, 2025, to June 9, 2025, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Boothwyn Pharmacy, LLC, located at 221 Gale Lane, Kennett Square, PA 19348. During the inspection, the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk.FDA issued a Form FDA 483 to your firm on June 9, 2025. FDA acknowledges receipt of your facility’s responses, dated July 1, 2025, and July 31, 2025. FDA further acknowledges that on July 9, 2025, your firm initiated a voluntary recall of all drug products, within expiry, with out-of-specification (OOS) results, including all drug product lots/sub lots that were filled from the same bulk stock solution. FDA also acknowledges that you ceased production of all GLP-1 drug products intended to be sterile and, on August 20, 2025, notified FDA of an intent to resume production of such products. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).A. Compounded Drug Products Under the FDCASection 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].B. Violations of the FDCAAdulterated Drug ProductsThe FDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigators observed that:1. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.2. Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.Additionally, the FDA investigators noted that your firm released and distributed drug products with strengths that differed from their labeled amounts. For example, your Fluorescein 2% Ophthalmic Solution was subpotent (lots # 01242025@(b)(4), potency of 85.865% and 03272025@(b)(4), potency of 76.1475%). Under section 501(b) of the FDCA [21 U.S.C. § 351(b)], a drug is deemed to be adulterated if it purports to be or is represented as a drug the name of which is recognized in an official compendium and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Accordingly, your Fluorescein 2% Ophthalmic Solution is adulterated under section 501(b) of FDCA.Furthermore, the FDA investigators noted that your firm released and distributed drug products that failed sterility testing. For example, your Tirzepatide 17mg/mL / Glycine 5mg/mL / Methylcobalamin 5mg/mL Injection (lot # 04072025@(b)(4)). In addition, the investigators noted that your firm released and distributed drug products with strengths that differed from their labeled amounts. For example, your Semaglutide 2.5mg/mL Injection was subpotent (lot # 03042025@(b)(4), potency of 79.876%) and your Tirzepatide 10mg/mL Injection was subpotent (lots # 01172025@(b)(4), potency of 86.779% and 02112025@(b)(4), potency of 89.13%). Under section 501(c) of the FDCA [21 U.S.C. § 351(c)], a drug is deemed to be adulterated if it is unrecognized in an official compendium and its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess. Accordingly, your Semaglutide 2.5mg/mL Injection and Tirzepatide 10mg/mL Injection are adulterated under section 501(c) of the FDCA.Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.Misbranded Drug ProductsThe strength of compounded drugs, for example your Fluorescein 2 % Ophthalmic Solution, Semaglutide 2.5mg/mL Injection, and Tirzepatide 10mg/mL Injection, differed from and fell below their labeled strength. Under section 502(a) of the FDCA [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Because the labeling of these drug products is false or misleading, they are misbranded under section 502(a) of the FDCA. The introduction or delivery for introduction into interstate commerce of these drug products therefore violates section 301(a) of the FDCA. It is also a prohibited act under section 301(k) of the FDCA to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.C. Corrective ActionsWe have reviewed your firm’s responses to the Form FDA 483. We further acknowledge that on July 9, 2025, your firm initiated a voluntary recall of all drug products, within expiry, with OOS results, including all drug product lots/sub lots that were filled from the same bulk stock solution. We also acknowledge that you ceased production of all GLP-1 drug products intended to be sterile and, on August 20, 2025, notified FDA of an intent to resume production of such products.Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:1. Regarding the repeat deficiencies identified in your smoke studies, your firm indicated that new smoke studies were performed on 07/30/2025 using protocols(b)(4)and(b)(4). However, you did not provide copies of these protocols and the corresponding new smoke studies. Without this supporting documentation, your firm’s assertion that the new smoke studies demonstrate and reflect the following corrective actions cannot be verified:a. “Updated smoke studies will clearly demonstrate that ISO 5 air is not compromised by air entering from the surrounding ISO 7 zone, using improved camera positioning and multiple angles to ensure complete visibility of the airflow boundary.”b. “Studies will accurately reflect production practices, including the appropriate use of one or more operators when applicable, and all roles and workflows will be documented and aligned with routine compounding procedures.”c. “First air protection over critical items such as bulk solution containers, stopper trays, and vial caps will be explicitly visualized, with clear footage showing that airflow remains unidirectional and undisturbed across all critical points.”d. “The issues observed in videos from BSC [Biological Safety Cabinet] units CEC#01983 and CEC#02166, such as stagnant airflow, arched patterns, backflow, and handling techniques, will be rectified by updated studies conducted under revised aseptic workflows. Technician retraining and procedural modifications have already begun to address these technique-related risks.”e. “[Camera] positioning and lighting have been optimized to ensure that first pass air is clearly visible over all active work areas, with no blind spots during critical manipulations.”In addition, you provided aseptic visual aids (Exhibit 12a - Aseptic Visual Aids, Pg. 79) that depicted airflow patterns in the ISO 5 BSC. These visual aids showed turbulence and no first air observed in the central area near the work surface (or deck) due to the air being pulled by the front and back vents inside the BSC. Given that your firm produces the majority of drug products intended to be sterile on the deck of a BSC, it remains unclear whether your firm has assessed and modified your aseptic procedures to adequately address this airflow deficiency.2. Regarding your production areas having surfaces that are difficult to clean or contain porous, particle generating surfaces, your firm provided several documents: the reconstruction floor plan for the remodeling of PS-112 cleanroom suite, the construction proposal and repairs punch list, and images of the ceiling tiles and walls of the newly remodeled area still under construction. However, you did not include adequate information or supporting documentation for review, including but not limited to:a. Specification documentation of the ceiling tiles used in the remodel;b. Documentation demonstrating these tiles are suitable for pharmaceutical use and cleaning protocols;c. Updated cleanroom certification report; andd. Environmental monitoring data for the remodeled cleanroom suite.Based on the images provided in your responses, it is unclear whether the ceiling tiles were properly caulked or if gaps exist between the ceiling tiles. Additionally, it remains unclear whether these newly constructed cleanroom areas meet the standards required to support the resumption of sterile production.While your responses indicate that the original interior walls in rooms PS-112 and PS-112A were replaced with PVC (including in the newly created room PS-114), insufficient information or supporting documentation were provided for review, including but not limited to:a. Specification documentation for the PVC wall paneling; andb. Documentation demonstrating that these PVC paneling are appropriate for pharmaceutical use and cleaning.Regarding your responses related to other adulteration issues, the following corrective actions appear deficient:1. Regarding your firm releasing drug products where strength differs from, or quality or purity falls below, that which the products purport or are represented to possess, your firm’s Standard Operating Procedures (SOP) contain conflicting provisions regarding release of drug products intended to be sterile prior to receiving final sterility testing results raising significant concerns about product quality and patient safety. In your response, you provided SOP ID: CP.GENCMPD.016.001 Compounded Sterile Preparation Batch Release which states, “(b)(4)." However, section 6.5.1 of the same SOP states, “(b)(4).” These two statements in the same SOP appear to be contradictory, and you have not provided any scientific justification for releasing ophthalmic drug products intended to be sterile prior to receiving the final sterility test results, nor clarified whether patients or prescribers will be notified of the “at risk” status. This concern is heightened given your firm’s documented history of sterility failures of drug products intended to be sterile, where patients were not notified of these failures.Furthermore, SOP ID: CP.GENCMPD.016.002 Batch Release Record, section 6.4.2 states, “If risk release is authorized by patient or prescriber, the Lab pharmacist may retrieve the products required for that specific RX from the designated hold area.” This provision indicates that any sterile drug product may be released “at risk”, without limiting this practice to ophthalmic preparations or excluding other categories of human drug products intended to be sterile. Additionally, the procedure does not specify whether you would inform the prescribers or patients in cases where the drug product subsequently fails sterility testing. Based on these SOPs, your firm's actual policy for “at risk” product release remains unclear, creating potential compliance issues and patient safety risks.You acknowledged that the release of compounded preparations that were OOS “reflects a deviation from [your] internal quality assurance procedures and [your] obligation to notify patients and prescribers upon discovery of any compromise to product strength, sterility, or potency.” However, you did not provide corrective actions addressing this deviation for failure to notify patients and prescribers when OOS’s were identified.Section 6.8 SOP ID: CP.GENCMPD.016.001 states, “Any OOS results must be immediately reported to quality and the pharmacist-in-charge. Investigation and root cause analysis should be performed when applicable per SOP QA.CAPA.016.001 Variance and OOS Investigations. A recall and customer notification procedures shall be followed when applicable.” This language indicates that investigation, root cause analysis, recall, and customer notification are only required "when applicable” rather than for every OOS occurrence. In addition, the SOP lacks defined timeframes for both patient/prescriber notification and investigation procedures following OOS occurrences.In addition, during the inspection, investigators reviewed 23 variance/OOS investigation reports from November 2024 through May 2025; none of these reports followed your SOP for investigating OOS results, and none of the investigations included documentation of contacting the patient by your firm. Of these 23, nineteen variance/OOS investigations remained open at the time of the inspection. It remains unclear whether these variance/OOS investigation reports have since been closed and whether the affected patients and/or their healthcare providers have been notified. There is no assurance that you will adhere to your own SOP procedures moving forward.Your responses did not identify or discuss the root cause(s) for the numerous sterility and potency OOS results for your drug products intended to be sterile. Between July 2, 2024 and May 1, 2025, your firm distributed drug products intended to be sterile that failed to meet sterility and potency specifications, including(b)(4)lots with sterility failures and approximately(b)(4)lots with potency failures (for human use). Given the substantial number of OOS results at your facility, particularly potency failures, section 6.1.2 of your SOP ID: CP.GENCMPD.016.001 Compounded Sterile Preparation Batch Release states: “(b)(4).” However, this section suggests you conduct potency testing on a selective basis rather than testing every lot or sub lot that is produced.Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A.FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.D. ConclusionThe violations cited in this letter are not intended to be an all-inclusive statement of violations 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 your firm complies with all requirements of federal law, including FDA regulations.You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time in which you will do so.Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov. In your response, refer to the Warning Letter Number above (# 717525) and include a subject line that clearly identifies the submission as a Response to Warning Letter.Sincerely,/S/Matthew J. LashActing DirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA UPSReference #:320-26-38Product:Drugs、Over-the-Counter DrugsRecipient:Ms. Maria EsparzaPresident and OwnerSignature Formulations, LLC5446 W Roosevelt St., Ste 101Phoenix,AZ85043United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-38January 21, 2026Dear Ms. Esparza:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Signature Formulations LLC., FEI 3011368010, at 5446 W Roosevelt St., Ste 101., Phoenix, from July 21 to 29, 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 August 29, 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 failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)).You manufacture(b)(4)over-the-counter (OTC)(b)(4)drug products and(b)(4)containing drug products in a shared facility, using multiple pieces of shared equipment. For example,(b)(4)was used to manufacture(b)(4)containing(b)(4)prior to manufacturing ORL kids bubblegum toothpaste. You manipulate and manufacture drugs with potent active ingredients without adequate facility separation to prevent cross-contamination of other drug products.Your(b)(4)drug products contain(b)(4). Contamination of(b)(4)drug products with potent(b)(4)presents significant risk to patient safety.In your response, you state that “exhaust systems or other systems to control contaminants are under study.” However, our investigation identified use of non-dedicated equipment in a shared facility. Your response is inadequate because it does not address how you will ensure there are adequate facility and equipment controls to prevent cross contamination.Contamination is generally nonuniformly distributed. Data obtained from retrospectively testing a small proportion of a batch (e.g., retain samples) is limited in its ability to retrospectively assess the extent of contamination in other portions of a batch. The lowest or highest results obtained from testing a small sample size is unlikely to reveal the true range of minimum and maximum contamination level that exists in a batch exposed to the contamination hazards identified at your firm. Consequently, the range of variability of contamination levels in batches produced by your firm remain characterized by substantial residual uncertainty. Because of the limitations of retrospective testing in gaining a representative understanding of the entire lot, testing retain samples alone is insufficient to determine the scope of the contamination issues and mitigate the associated risks. Further evaluation and scientific rationale is needed in your firm’s risk assessment to reflect the nature of cross-contamination events and determine the degree of cross-contamination risk that may be posed to a portion of marketed batches.On December 2, 2025, FDA held a teleconference with you recommending you consider removing any batches of ORL Kid’s Natural Toothpaste and ORL Kid’s mouthwash currently in distribution from the U.S. market.On December 8, 2025, you issued a voluntarily recall of ORL kids bubblegum toothpaste lot number 250520P4-05/27 and ORL kids bubblegum mouthwash lot number 250505P9-05/27 due to potential contamination with exogenous hormones.In response to this letter, provide:A comprehensive, independent assessment of the design and control of your firm’s manufacturing operations with a detailed and thorough review of all(b)(4), and other active ingredient, cross-contamination hazards.Confirmation of whether you will discontinue manufacturing drugs on shared equipment in your facility and implement appropriate controls to prevent cross-contamination.Your plan to perform testing to identify(b)(4)contamination in all your drug products. Any testing performed to identify(b)(4)contamination should be scientifically sound, include appropriate sampling plans and test procedures, including methods that are appropriately validated, suitable for intended use, and sufficiently sensitive.A detailed risk assessment addressing the hazards posed by distributing drug products potentially contaminated with(b)(4). Specify actions you will take in response to the risk assessment, such as customer notifications and product recalls.A summary of updated standard operating procedures (SOPs) that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.2. 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 failed to ensure your cleaning procedures are adequate to prevent cross-contamination of(b)(4)OTC drug products with the potent(b)(4)(e.g.,(b)(4)). For example, you have inadequate cleaning validation for your non-dedicated manufacturing equipment.In your response, you state that your cleaning and sanitization SOP has been updated and that dirty and damaged equipment components have been replaced. Cleaning to prevent cross contamination with potent ingredients on shared equipment is extremely difficult and unacceptable.(b)(4)in(b)(4)OTC(b)(4)products pose a significant risk to public health. In children, exposure to even low levels of(b)(4)can lead to developmental and reproductive harm. Therefore, dedication of facilities and equipment should be considered.In response to this letter, provide:A risk assessment for all drug products you have previously produced on shared equipment. For each product, assess the risk of potential contamination due to the shared equipment. Also, provide your plans for addressing the product quality and patient safety risks for any product still in distribution, including potential recalls or market withdrawals.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 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 corrective action and preventive action (CAPA) plan based on the retrospective assessment of your cleaning and disinfection program. Include appropriate remediations to your cleaning and disinfection processes and practices and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning and disinfection. Describe improvements to your cleaning and disinfection program, including enhancements to cleaning effectiveness, improved ongoing verification of proper cleaning and disinfection execution for all products and equipment, and all other needed remediations.Evidence of the establishment of a 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 residue difficult to cleano Swabbing locations for areas that are most difficult to cleano Maximum hold times before cleaningThe 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 have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)).You released finished drug products without adequate testing. For example, you did not perform adequate microbiological monitoring and chemical testing on your finished drug products. Further, you did not adequately validate the method you use for assay testing your bulk(b)(4)containing drug products.Your response states that you do not “produce any products that are drugs.” Your response is inadequate because your drug products are subject to CGMP requirements. Further, your response does not indicate that you will test your finished drug products to ensure they meet appropriate specifications.Drug product batches must be tested for identity, strength, and purity prior to release. Testing is essential to ensure that the drug products you manufacture conform to all predetermined quality attributes appropriate for their intended use. Without adequate finished product release testing, you do not have scientific evidence that each batch of drug product conforms to appropriate specifications before release.In your 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 specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.An action plan and timelines for conducting full chemical and microbiological testing of reserve samples to determine the quality of all batches of drug products distributed to the United States that are within expiry as of the date of this letter.A summary of all results obtained from testing reserve samples from each batch. If this testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.4. Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)).You lacked adequate quality unit (QU) oversight for the manufacture of your drug products. For example, your QU failed to ensure:Adequate testing of incoming raw materials, including performing identity testing of each shipment of each component (e.g.(b)(4)) used in the manufacture of your drug products (21 CFR 211.84(d)(2))Adequate laboratory controls and specifications (21 CFR 211.160(b))Adequate design and procedures for production and process controls for drug products and for maintenance and monitoring of your(b)(4)used to manufacture drug products (21 CFR 211.100(a))Adequate investigations into non-conformances (21 CFR 211.192)Establishment of a written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a))In your response, you again state that you do not manufacture any drug products. You further state that you updated your procedures to more clearly define the roles of the QU. Your response is inadequate because you do not address how you plan to ensure that your quality unit has sufficient resources to carry out its responsibilities and consistently ensure drug quality. You also do not address how you will maintain completeness and accuracy of the records used for batch release and other quality review decisions.Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. 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.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/media/71023/download.In your 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 productsAlso 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.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 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 for safety, identity, strength, quality, and purity. See FDA’s guidance documentContract Manufacturing Arrangements for Drugs: Quality Agreementsat https://www.fda.gov/media/86193/download.Repeat Violations at FacilityIn a previous warning letter CMS 545017, dated July 31, 2018, FDA cited similar CGMP violations. You proposed specific remediation for these violations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs are inadequate.Drug Consultant RecommendedIt is the responsibility of each person marketing and distributing drug products in the United States to comply with the requirements of the FD&C Act and its implementing regulations. Should you have questions concerning the laws and regulations for the products manufactured by your firm, including the products manufactured for contract customers, we recommend that you retain the services of a drug law consultant for assistance.Because you failed to correct repeat violations, you should engage a consultant qualified as set forth in 21 CFR 211.34 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 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 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 3011368010 and ATTN: Zachary Bogorad.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:26-HFD-45-02-01Product:DrugsRecipient:Mark S. Dacey, M.D.425 South Cherry Street, Suite 907Denver,CO80246-1242United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 26-HFD-45-02-01Dear Dr. Dacey:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between October 23 and November 8, 2024. The investigator representing FDA reviewed your conduct of the following clinical investigations:• Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4)• 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 the Form FDA 483, Inspectional Observations. We acknowledge receipt of your December 3, 2024, 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 December 3, 2024, 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. 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 50.23 and 21 CFR 50.24, 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.You failed to obtain legally effective informed consent for Subject(b)(6), who was enrolled in Protocol(b)(4), before the collection of optional aqueous humor samples. Specifically, Protocol(b)(4)required subjects to sign the appropriate informed consent form for participation in the collection and submission of optional aqueous humor samples for pharmacokinetic and pharmacodynamic assessments. However, Subject(b)(6)underwent the collection of aqueous humor from the study eye on March 5, 2024 (Week 20), even though the subject declined consent on September 26 and October 18, 2023, for the collection and submission of optional aqueous humor samples.In your December 3, 2024, written response to the Form FDA 483, you stated that the site inadvertently collected the aqueous humor sample for Subject(b)(6)at the March 5, 2024 (Week 20) visit. You stated that on March 20, 2024, the medical monitor notified the site of the incident. Following this notification, the issue was reported to the IRB, and Subject(b)(6)was notified of the inadvertent aqueous humor sample collection at their next visit. You stated that the request for sample destruction was submitted to the central lab, and the sponsor confirmed the destruction. You also stated that to prevent a similar occurrence, the site will use quick-reference labels on subjects’ source binders and/or the site will use an informed consent form tracking feature for optional procedures in the site’s RealTime Clinical Trial Management System (CTMS). Further, you stated that the labeling of source binders and/or notation in the RealTime CTMS will be implemented at the Principal Investigator’s new practice location to ensure compliance for current and future research activities.While we acknowledge the corrective and preventive actions that your site has taken and plans to take, your written response is inadequate because you did not provide sufficient details about how you, as the clinical investigator, will ensure adequate oversight of study procedures. Specifically, you did not provide information about how the labeling of source binders or notation in the RealTime CTMS will be implemented at your site, including training for you as the clinical investigator and for the site staff, so that these procedures are used to accurately determine a subject’s consent for optional procedures during a clinical investigation. Without this information, we are unable to determine whether your corrective actions appear adequate to prevent similar violations in future clinical investigations.We also remain concerned that in this clinical investigation, it was clearly documented in Subject(b)(6)’s records that the subject twice declined consent, yet the optional sample collection procedure was performed. As a result, the subject was exposed to unnecessary potential risks from the performance of this procedure, such as blurred vision, bleeding on the surface of or inside the eye, damage to the lens of the eye, and inflammation or infection inside the eye.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 legally effective informed consent from subjects in accordance with 21 CFR part 50. Your failure to obtain informed consent before conducting study-related procedures jeopardizes the rights, safety, and welfare of subjects by denying them an 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. 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.Should you have any questions or concerns about this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov. Your written response and any pertinent documentation should be addressed to:Brittany L. Garr, MPHBranch ChiefCompliance Enforcement BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationBuilding 51, Room 535210903 New Hampshire AvenueSilver Spring, MD 20993Sincerely 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 Administration--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------DAVID C BURROW02/02/2026 01:23:10 PM

Delivery Method:VIA UPSReference #:320-26-42Product:Drugs、Over-the-Counter DrugsRecipient:Mr. Yanzhuan ZhengOwner/PresidentBio-Medical Pharmaceutical Manufacturing Corporation4311 South DriveHouston,TX77053United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-42February 5, 2026Dear Mr. Zheng:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Bio-Medical Pharmaceutical Manufacturing Corporation (Bio-Medical), FEI 1650090, at 4311 South Drive, Houston, from August 25 to 29, 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).In addition, we reviewed your firm’s drug listing submissions in FDA’s electronic Drug Registration and Listing System (eDRLS) and found that your firm has not fulfilled its drug listing obligations under 510(j) of the FD&C Act, U.S.C. 360(j), and 21 CFR 207, which is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).We reviewed your September 8, 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.CGMP Violations1. 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. Your firm also failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.113(b) and 211.42(c)(10)).You are a contract manufacturing organization (CMO) for an over-the-counter (OTC)(b)(4)drug product for the drug product owner,(b)(4). You manufacture this(b)(4)drug product without adequate facility design, controls, and procedures to ensure sterility of the containers/closures and finished drug product. Your firm neither aseptically processed nor terminally sterilized your product. If(b)(4)drugs are not sterile, they pose an unacceptable risk to patients, including infection and potential for(b)(4).During the inspection, you acknowledged you lack an adequate understanding of CGMP and the requirements for manufacturing(b)(4)drug products.Our investigators observed that your facility lacked classified cleanrooms for production, as well as ISO 5 conditions for aseptic filling and sealing. Furthermore, your manufacturing facility lacks appropriate equipment and practices, including environmental controls to ensure your(b)(4)drug product is sterile. Your drug products intended to be sterile are at risk of contamination due to the insanitary conditions observed at your facility. This includes the condition of the production tank, filling lines lying on an unclean floor made of a rough, porous surface (e.g., concrete) in an open area, lack of appropriate sanitary fittings, and the general overall poor conditions of the facility for manufacturing drug products intended to be sterile. Additionally, investigators observed stagnant(b)(4)in contact with distribution and sampling equipment, including hoses that dispense(b)(4)used for drug product formulation.Your response is inadequate because you do not provide an adequate plan for corrective action and preventive action (CAPA) for manufacturing(b)(4)drug products intended to be sterile. Your response lacks an appropriate action plan to ensure sterility of the product. Sterilization, aseptic filling, and closing operations must all be appropriately designed, qualified, and executed under appropriate conditions, including filling and sealing in a high-quality clean environment.It should also be noted that, whenever feasible, terminal sterilization should be used to render products sterile.See FDA’s guidance documentSterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practiceto help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/media/71026/download.In response to this letter, provide: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:o All human interactions within the ISO 5 areao Equipment placement and ergonomicso Air quality in the ISO 5 area and surrounding roomo Facility layouto 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.An assessment of the potential for terminal sterilization of your(b)(4)drug products.2. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. Your firm also 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. Additionally, your firm also 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 211.63 and 211.100(a) and 211.67(a)).Inadequate EquipmentYou use(b)(4)as a component to manufacture your sterile and non-sterile OTC drug products. Your(b)(4)system is inadequately designed and maintained for its intended use. For example, your ambient non-circulating(b)(4)system included dead legs which could foster the development of biofilms. When not in use, stagnant(b)(4)remained in the sampling hose and distribution system. You use(b)(4)from this system to manufacture your drug products.In your response, you state that you removed the dead legs and revised your procedure for hose storage. You also state that you will continuously operate your(b)(4)system, record maintenance events, and increase sampling frequency. Your response is inadequate because you failed to replace the unsuitable(b)(4)system observed during the inspection with a new appropriately designed system. You also failed to provide corresponding plans for system validation. Additionally, you lack plans for maintenance, control, and appropriate testing and monitoring for(b)(4), as well as appropriate microbiological tests.The(b)(4)system must be adequately designed for its intended use and properly maintained and controlled. It is essential that(b)(4)is routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.Lack of process validationIn addition to inadequate facility and process design, you lacked adequate qualification of equipment and validation of processes used to manufacture your drug products. The “current validated” sterilization manufacturing process provided in your response is fundamentally flawed as evidenced by:insanitary conditions in your facility;use of a(b)(4)not sufficient for sterile(b)(4);reliance on a manually intensive process;lack of batch sterility testing (your firm performed “CFU testing”).Also, you lacked other basic elements of a reliable sterile manufacturing operation needed to support a validated process.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 to 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. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality are necessary to ensure that you maintain a stable manufacturing operation throughout the product lifecycle.See FDA’s guidance documentProcess Validation: General Principles and Practicesfor general principles and approaches that FDA considers appropriate elements of process validation, at https://www.fda.gov/media/71021/download.Lack of cleaning validationYou manufacture sterile and non-sterile OTC drug products and cosmetics on non-dedicated manufacturing equipment in a shared area. You failed to conduct cleaning validation studies to demonstrate that your cleaning, disinfection, and sterilization practices, as applicable, are adequate to remove contaminants and residues from your drug product manufacturing equipment.Your procedure for cleaning production equipment used to manufacture(b)(4)drug products, “Special Cleaning Procedure For Other Equipment,” relies on(b)(4)(e.g.,(b)(4)) as the “sterilization” agent. While(b)(4)can be an effective disinfectant, your procedure lacks critical elements such as validated contact times, concentration verification, residue removal, and demonstration that the cleaning process consistently achieves the sterility assurance levels required for sterile drug products.Inadequate removal of active ingredients and residues from manufacturing equipment during cleaning can result in cross-contamination of the drug products.In response to this letter, provide:Your 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.A comprehensive remediation plan for the design, control, and maintenance of the(b)(4)system.Validation report for the(b)(4)system obtained after an appropriately designed system has been installed. Include the system validation protocol, the complete test results, and the final validation report.Your total microbial count limits to monitor whether this system is producing(b)(4)suitable for the intended uses for each of your products. Also, explain whether you intend to conduct endotoxin testing.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 or within expiry. Specify actions that you will take in response to the risk assessment, such as customer notifications and product recalls.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 appropriate process performance qualification (PPQ) 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 CAPA plan, based on the retrospective assessment of your cleaning and disinfection program, that includes appropriate remediations to your cleaning and disinfection processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning and disinfection. Describe improvements to your cleaning and disinfection program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning and disinfection execution for all products and equipment; and all other needed remediations.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 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 have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms. Additionally, your firm failed to conduct appropriate laboratory testing to determine whether each batch of drug product purporting to be sterile and pyrogen-free conforms to such requirements (21 CFR 211.165(a) and 211.165(b) and 211.167(a)).You failed to conduct adequate release testing of all your drug products. For example:You did not conduct appropriate laboratory testing, including sterility testing, for each batch of(b)(4)drug product that is required to be sterile.You did not conduct appropriate laboratory testing of each batch of drug product, such as(b)(4), required to be free of objectionable microorganisms.In your response, you specify the microbiological media lots used to perform testing are validated. Your response is inadequate. For example, media used, sample size, incubation time and temperatures, and other elements of your test methods are inappropriate. You also do not provide sufficient details as to how you will ensure that your laboratory or your contract testing laboratories will perform adequate release testing on all OTC finished drug products. In addition to compendial methods, additional batch testing may be necessary to fully identify microbes that, based on the intended use of your non-sterile products, may be objectionable.Moreover, you failed to perform appropriate sterility testing on your(b)(4)drug products prior to batch release. It is essential that you conduct sterility testing on(b)(4)drug products prior to making batch disposition decisions. Additionally, you do not consider a risk assessment or retrospective review of products that have been released without appropriate testing.Full release testing, including for identity, strength, and purity, must be performed prior to batch release and distribution. Without appropriate testing, you do not have adequate scientific evidence to ensure that your drug products conform to established specifications before release.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 specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.o 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.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.Drug Listing ViolationsSection 510(j) of the FD&C Act, 21 U.S.C. 360(j), 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 207.41(a), a registrant must list each drug that it manufactures for commercial distribution. Your firm failed to provide listing information for the drug “(b)(4)Solution.” Therefore, your firm has failed to provide listing information for a drug in accordance with 510(j) of the FD&C Act, 21 U.S.C. 360(j), which is prohibited under section 301(p) of the FD&C Act, 21 U.S.C. 331(p).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.Drug Recall and Suspended DistributionOn November 4, 2025, FDA held a teleconference with you. We recommended you remove any batches of OTC(b)(4)solution (e.g.,(b)(4)Solution) currently in distribution and within expiry from the U.S. market. We also recommended you consider ceasing further distribution. Your firm erroneously indicated that your(b)(4)solution is not a drug product. However, be advised that this(b)(4)and other drug products that your firm has manufactured are all subject to CGMP requirements.The(b)(4)solutions manufactured by your firm are distributed by(b)(4).On(b)(4), your customer(b)(4)notified FDA that it suspended distribution of(b)(4)on(b)(4).On(b)(4)initiated a voluntary recall of all batches of(b)(4)within expiry.In response to this letter, clarify whether you intend to continue manufacturing(b)(4)drugs required to be sterile for the U.S. market at this facility. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your response, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA.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 evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit1of 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.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 1650090 and ATTN: William Fowler.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______________________1i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.