行政处罚相对人类别:法人及非法人组织行政处罚决定书文号:穗海市监处罚〔2026〕12号处罚类别:警告;罚款;没收违法所得、没收非法财物罚款金额(万元):7.5没收违法所得、没收非法财物的金额(万元):0.790058暂扣或吊销证照名称及编号:违法事实:经查明，当事人主要从事药品零售经营活动。其于2024年11月30日至2024年12月22日在其经营的拼多多网店“葆滴大药房旗舰店”销售的252盒“郝其军复方皂矾丸”（批准文号：国药准字Z61020457；生产企业：陕西郝其军制药股份有限公司）系未从药品上市许可持有人或具有药品生产经营资格的企业购进，根据调查取得的证据，当事人上述违法行为的货值金额为7900.58元，违法所得为7900.58元。另查明，当事人未按规定在其仓库陈列药品及未按规定录入、修改、保存计算机系统数据，构成未遵守药品经营质量管理规范经营药品的违法行为。处罚依据:当事人无法提供上述药品合法采购查验资料的行为违反了《中华人民共和国药品管理法》第五十五条“药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品；但是，购进未实施审批管理的中药材除外”的规定，构成未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的违法行为。对于当事人的违法行为，应根据《中华人民共和国药品管理法》第一百二十九条“违反本法规定，药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的，责令改正，没收违法购进的药品和违法所得，并处违法购进药品货值金额二倍以上十倍以下的罚款；情节严重的，并处货值金额十倍以上三十倍以下的罚款，吊销药品批准证明文件、药品生产许可证、药品经营许可证或者医疗机构执业许可证；货值金额不足五万元的，按五万元计算。”的规定当事人未按规定在其仓库陈列药品及未按规定录入、修改、保存计算机系统数据违反《药品经营质量管理规范》第五十九条的“各类数据的录入、修改、保存等操作应当符合授权范围、操作规程和管理制度的要求，保证数据原始、真实、准确、安全和可追溯。”规定，构成未遵守药品经营质量管理规范经营药品的违法行为。对于当事人的违法行为，应根据《中华人民共和国药品管理法》第一百二十六条“本法另有规定的情形外，药品上市许可持有人、药品生产企业、药品经营企业、药物非临床安全性评价研究机构、药物临床试验机构等未遵守药品生产质量管理规范、药品经营质量管理规范、药物非临床研究质量管理规范、药物临处罚内容:当事人无法提供上述药品合法采购查验资料的行为违反了《中华人民共和国药品管理法》第五十五条“药品上市许可持有人、药品生产企业、药品经营企业和医疗机构应当从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品；但是，购进未实施审批管理的中药材除外”的规定，构成未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的违法行为。对于当事人的违法行为，应根据《中华人民共和国药品管理法》第一百二十九条“违反本法规定，药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的，责令改正，没收违法购进的药品和违法所得，并处违法购进药品货值金额二倍以上十倍以下的罚款；情节严重的，并处货值金额十倍以上三十倍以下的罚款，吊销药品批准证明文件、药品生产许可证、药品经营许可证或者医疗机构执业许可证；货值金额不足五万元的，按五万元计算。”的规定给予当事人行政处罚。鉴于当事人违法行为持续时间较短，为五年以内第一次实施该性质的违法行为，符合减轻处罚的情形，本局责令当事人立即改正未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的违法行为，没收违法所得7900.58元，处罚款75000元。当事人未按规定在其仓库陈列药品及未按规定录入、修改、保存计算机系统数据违反《药品经营质量管理规范》第五十九条的“各类数据的录入、修改、保存等操作应当符合授权范围、操作规程和管理制度的要求，保证数据原始、真实、准确、安全和可追溯。”规定，构成未遵守药品经营质量管理规范经营药品的违法行为。对于当事人的违法行为，应根据《中华人民共和国药品管理法》第一百二十六条“本法另有规定的情形外，药品上市许可持有人、药品生产企业、药品经营企业、药物非临床安全性评价研究机构、药物临床试验机构等未遵守药品生产质量管理规范、药品经营质量管理规范、药物非临床研究质量管理规范、药物临床试验质量管理规范等的，责令限期改正，给予警告；......”的规定，本局责令当事人立即改正违法行为，给予警告。综上，本局责令当事人立即改正未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品和未遵守药品经营质量管理规范经营药品的违法行为，并作出如下行政处罚：1.警告；2.没收违法所得7900.58元；3.罚款75000元。以上合计罚没82900.58元。违法行为类型:药品经营企业违法行为行政相对人名称:广州快药箱大药房连锁有限公司行政相对人代码:统一社会信用代码组织机构代码工商登记码税务登记号事业单位证书号社会组织登记证号91440101MA5AQN0A1L法定代表人:严刚处罚决定日期:2026-01-09公示截止期:2029-01-09处罚机关:广州市海珠区市场监督管理局数据来源单位:广州市市场监督管理局（广州市知识产权局）

Delivery Method:Via EmailReference #:320-26-36Product:DrugsRecipient:Steven F. PressmanCEOWinder Laboratories, LLC716 Patrick Industrial LaneWinder,GA30680United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-36January 7, 2026Dear Mr. Pressman:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Winder Laboratories, LLC, FEI 3008694072, at 716 Patrick Industrial Lane, Winder, Georgia, from July 14 to August 5, 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 26, 2025, response to our Form FDA 483 in detail, and we acknowledge receipt of your subsequent correspondenceDuring our inspection, our investigators observed specific violations, including but not limited to the following:1. 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 of purity of the drug product beyond the official or other established requirements and you failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(a) and (b))).Failure to Clean EquipmentYou have not demonstrated that your cleaning practices are adequate to remove contaminants from the nondedicated equipment used to manufacture your prescription drug products, including(b)(4)tablets and(b)(4)tablets. Multiple pieces of manufacturing equipment, including the(b)(4)and the Tablet Press, were observed to have drug product residue and oxidized metal surfaces, which were documented as being clean and were released by your quality unit. Additionally, the dedicated(b)(4)equipment showed visible product residue, oxidized metal, and foreign material, despite being cleaned and released by your quality unit.Similar equipment cleaning deficiencies were cited during your previous FDA inspections, indicating that your cleaning procedures are insufficient to prevent contamination that could alter the safety, identity, strength, quality, or purity of your drug products.Additionally, your firm's voluntary recall of(b)(4)mg(b)(4)tablets due to(b)(4)mg tablets being found inside the bottle could be associated to inadequate line clearance of equipment prior to use.In your response, you state that you have implemented a new procedure requiring the use of a flashlight to detect residues or surface abnormalities not visible to the naked eye, and you provided training on the revised procedures.Your response is inadequate because you do not provide evidence that your cleaning methods are appropriate and effective, nor do you assess the impact of your inadequate cleaning processes on drug product that is currently on the market and within expiry.Failure to Maintain EquipmentYou failed to adequately maintain your equipment. For example, the metal detection equipment MFG-1276 was found to be nonfunctioning during the inspection. Your preventive maintenance procedures were also inadequate, focusing only on the metal detector’s physical appearance rather than its operational functionality.Additionally, your executed metal detector qualification protocol did not include the qualification of the metal detector MFG-1276.These equipment maintenance failures compromise your ability to detect and prevent contamination. Notably, a metal screw was found in a sealed bottle of(b)(4)mg, lot(b)(4).In your response, you stated that you halted all packaging activities and did not resume packaging operations until the metal detectors had been repaired, and preventive maintenance had been performed.Your response is inadequate because you did not commit to completing the equipment qualification for the metal detector or describe how you will periodically requalify it. Additionally, you did not commit to conducting a retrospective risk assessment for batches that were processed while the metal detector was not functioning properly.In response to this letter, provide the following: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 actions and preventive actions (CAPA) plan, based on the retrospective assessment of your cleaning program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning. Describe improvements to your cleaning program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning execution for all products and equipment; and all other needed remediations.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 the 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.Process performance protocol(s), and written procedures for qualification of equipment and facilities and your program for qualification of your equipment and facility.2. Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58).You failed to adequately maintain your facility in a good state of repair. Specifically, we observed the following deficiencies during the inspection:Gaps were observed in the protective wall, covering the original underlying wall surface in the(b)(4)machine room, thus creating areas that are difficult to clean.An unknown brown-yellow material was visible in the wall gaps located near the(b)(4)equipment, indicating potential contamination risks in the manufacturing environment.A ceiling vent was improperly secured with transparent tape in the tablet room, demonstrating substandard facility maintenance practices.The walls of the room housing the(b)(4)were unfinished and not cleanable.In your response, you state that you immediately halted all manufacturing operations and promptly took corrective actions to address the specific deficiencies. You also indicated that you would not resume manufacturing operations until all repairs were completed, and the rooms met the required standards for cleanliness and maintenance.Your response is inadequate. You did not provide a systemic and comprehensive CAPA plan to ensure that your facility is and remains in a good state of repair.It is essential that your facility be in a good state of repair to prevent contamination and to ensure its ongoing suitability for drug manufacturing.In response to this letter, provide the following: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.Documented evidence (for example, photos) of any repairs made to your facilities and equipment.Quality SystemsYour firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.CGMP Consultant RecommendedBecause you failed to correct repeat violations, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Repeat Observations at FacilityIn previous inspections, dated July 18, 2018; February 11, 2022; and February 3, 2023, FDA cited similar CGMP observations, and you proposed specific remediation for these observations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.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. 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 3008694072 and ATTN: Chhaya Shetty.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

行政处罚相对人类别:法人及非法人组织行政处罚决定书文号:穗埔市监处罚〔2026〕17号处罚类别:罚款罚款金额(万元):1没收违法所得、没收非法财物的金额(万元):暂扣或吊销证照名称及编号:违法事实:当事人生产的“低中频多功能治疗仪”属于第二类医疗器械，其说明书、标签与注册证相关内容不一致，违反了《医疗器械监督管理条例》第三十九条第一款“医疗器械应当有说明书、标签。说明书、标签的内容应当与经注册或者备案的相关内容一致，确保真实、准确。”的规定，处罚依据:《医疗器械监督管理条例》（2021年修订）第八十八条：有下列情形之一的，由负责药品监督管理的部门责令改正，处1万元以上5万元以下罚款；拒不改正的，处5万元以上10万元以下罚款；情节严重的，责令停产停业，直至由原发证部门吊销医疗器械生产许可证、医疗器械经营许可证，对违法单位的法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入30%以上2倍以下罚款，5年内禁止其从事医疗器械生产经营活动：（一）生产条件发生变化、不再符合医疗器械质量管理体系要求，未依照本条例规定整改、停止生产、报告；（二）生产、经营说明书、标签不符合本条例规定的医疗器械；（三）未按照医疗器械说明书和标签标示要求运输、贮存医疗器械；（四）转让过期、失效、淘汰或者检验不合格的在用医疗器械。处罚内容:根据《医疗器械监督管理条例》第八十八条第二项的规定，考虑到涉案产品“低中频多功能治疗仪”经广东省医疗器械质量监督检验所检验，产品符合当事人发布的《低中频多功能治疗仪》产品技术要求，危害后果轻微，符合《广东省药品监督管理局药品监督管理行政处罚裁量适用规则实施细则》第十一条第（八）项规定的从轻情节，本局决定对当事人从轻给予以下行政处罚：罚款10000元。违法行为类型:医疗器械生产企业违法行为行政相对人名称:科鹏医疗器械(广州)有限公司行政相对人代码:统一社会信用代码组织机构代码工商登记码税务登记号事业单位证书号社会组织登记证号91440101618651120F法定代表人:黄仙慧处罚决定日期:2026-01-12公示截止期:2026-04-12处罚机关:广州市黄埔区市场监督管理局数据来源单位:广州市市场监督管理局（广州市知识产权局）

Delivery Method:Via EmailReference #:320-26-34Product:DrugsRecipient:Mr. Rushabh VoraManaging DirectorChemspec Chemicals Private LimitedPlot 3-C, Taluka PanvelNavi Mumbai410208MaharashtraIndiaccpl@chemspec.co.inIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-34December 23, 2025Dear Mr. Vora:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Chemspec Chemicals Private Limited, FEI 3004947391, located at Plot 3-C, Taluka Panvel, Navi Mumbai, Maharashtra, from July 28, 2025, to August 1, 2025.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your August 21, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific deviations including, but not limited to, the following.Failure of your quality unit to exercise its responsibility to ensure the API and intermediates manufactured at your facility are in compliance with CGMP.Your quality unit failed to ensure adequate document control over paper and electronic records. Your quality unit was not exercising its basic responsibilities for oversight and control of the adequacy and reliability of all CGMP data at your facility. In addition, your quality unit failed to ensure that employees involved in CGMP operations for APIs understand and adhere to data integrity principles. For example:Your quality unit failed to ensure that batch production records were prepared with complete information relating to the manufacture and control of each lot of API produced. You manufactured and released lots of APIs without creating or maintaining batch manufacturing records. Your quality unit failed to identify this deviation and did not investigate until our investigators cited it as a CGMP deficiency.You distributed multiple lots of the API(b)(4)without documenting review and release by the quality unit.Your quality unit kept two separate logbooks for the issuance of lot numbers which showed that two batch manufacturing records were issued for the same lot numbers. In addition, we observed two API batch records in use, in production, with neither an assigned control number nor any documentation that they had been issued by the quality unit.Your quality unit engaged in deficient data integrity practices. For example:o Your quality unit failed to control your process for replacing controlled documents. Your quality unit replaced original CGMP documents consisting of numerous pages of executed batch production records and a laboratory-testing record in which original pages were discarded or destroyed without a documented investigation. Your quality assurance manager stated that you do not maintain the original pages. We found blank forms used to replace controlled records in the production department with no indication that they had been issued by the quality unit.o Your quality unit allowed your production operators to retroactively complete CGMP information in batch production records for production steps performed by the previous(b)(4). Your quality unit did not start an investigation until this data integrity failure was pointed out during our inspection. We observed your(b)(4)production personnel – who had not performed or witnessed the previous(b)(4)operations – in the production office non-contemporaneously documenting CGMP information, such as weights and measures of components, solvents, and temperatures, on API batch records for operations performed by the previous(b)(4).Your response dated August 21, 2025, acknowledges multiple deficiencies in your documentation practices, including inconsistencies in batch manufacturing record issuance, missing quality assurance review, uncontrolled forms, and inadequate documentation oversight. You acknowledge that your quality unit is responsible for preparing, reviewing, and approving master production and control records, and for ensuring their accuracy, distribution, and reconciliation.You responded that you recovered approximately half of the original API batch manufacturing records. You stated that you will update your procedures to include a batch manufacturing record closure checklist and mandatory reconciliation of these records to ensure they are not lost. Additionally, you stated that you failed to document the release of lots because you do not have enough quality assurance personnel to review batch production records and release batches.You stated that you misclassified replacement of CGMP documents as administrative corrections, and you did not have procedures requiring an investigation when you replaced these documents. You stated your procedures will be updated to require original document retention and documented deviation investigations for all replacements.Your response is inadequate. You do not sufficiently address and reconcile all missing batch records. You do not provide results of any comprehensive retrospective evaluation, nor do you provide any testing data and release documentation.You do not provide a plan or procedures to holistically improve your document lifecycle controls, issuance traceability, and quality unit release processes. You do not provide results from comprehensively investigating past incidents of non-contemporaneous documentation, nor have you reconciled existing batch manufacturing records for completeness and release by the quality unit.You do not perform a comprehensive retrospective review of the replaced CGMP document pages. You do not provide any indication of the relevance of the original pages that were not maintained. You do not provide adequate revised procedures to ensure that original data will be recorded contemporaneously and indelibly.Complete and accurate batch production and control records must be contemporaneously documented to ensure that manufacturing processes are consistently followed and are reproducible. Additionally, incomplete manufacturing records deprive you of the ability to adequately investigate deviations.Reliability of data is fundamentally compromised when there is a failure to contemporaneously record and/or maintain complete and accurate records of testing conditions and results. Furthermore, the lack of reliable data compromises the ability of your quality unit to exercise its function of ensuring compliance to applicable standards.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your quality unit 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 quality unit oversight throughout your operations to evaluate adherence to appropriate practiceso A complete and final review of each batch and its related information before the quality unit disposition decisiono Oversight and approval of investigations and discharging of all other quality unit duties to ensure identity, strength, quality, and purity of all productsA complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, contemporaneous, original, accurate, and complete records throughout your operation.Data Integrity RemediationYour quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance documentData Integrity and Compliance With Drug CGMPfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers.We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for APIs or advanced intermediates distributed to the United States or intended for drug products subsequently distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including analytical data, manufacturing records, and all data submitted to FDA.Repeat Observations at FacilityIn a previous untitled letter dated February 5, 2025, FDA cited similar CGMP deviations. You proposed specific remediation for these deviations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of APIs are inadequate.Additional CGMP Guidance for APIsFDA considers the expectations outlined in ICH Q7 when determining whether APIs are manufactured in conformance with CGMP. See FDA’s guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of APIs at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients-guidance-industry.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.Failure to address any deviations may also result in the FDA refusing admission of articles manufactured at Chemspec Chemicals Private Limited, FEI 3004947391, located at Plot 3 - C, Taluka Panvel, Navi Mumbai, Maharashtra, 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 days1. Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3004947391 and ATTN: Brian Nicholson.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research_________________________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.

行政处罚相对人类别:法人及非法人组织行政处罚决定书文号:穗越市监处罚〔2026〕18号处罚类别:罚款罚款金额(万元):1没收违法所得、没收非法财物的金额(万元):暂扣或吊销证照名称及编号:违法事实:经查明：当事人在涉案产品“张辉燕舒润液”（备案号：粤G妆网备字2025272080）的化妆品备案过程提交了篡改的检验报告（GF00132****39538）。2025年9月3日，“张辉燕舒润液”（备案号：粤G妆网备字2025272080）化妆品备案已被取消。根据当事人提供的材料，本局认定当事人委托生产上述涉案化妆品共10瓶，单价0.2元/瓶，进价2元，销售总额为0元；其中3瓶送备案检测，剩余7瓶被备案受托人王林菲私自销毁。库存0瓶，库存货值为0元。综上，当事人生产上述涉案化妆品货值金额2元，违法所得为0元。处罚依据:《化妆品监督管理条例》（2021年1月1日起施行）第六十五条：备案时提供虚假资料的，由备案部门取消备案，3年内不予办理其提出的该项备案，没收违法所得和已经生产、进口的化妆品；已经生产、进口的化妆品货值金额不足1万元的，并处1万元以上3万元以下罚款；货值金额1万元以上的，并处货值金额3倍以上10倍以下罚款；情节严重的，责令停产停业直至由原发证部门吊销化妆品生产许可证，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上2倍以下罚款，5年内禁止其从事化妆品生产经营活动。　　已经备案的资料不符合要求的，由备案部门责令限期改正，其中，与化妆品、化妆品新原料安全性有关的备案资料不符合要求的，备案部门可以同时责令暂停销售、使用；逾期不改正的，由备案部门取消备案。　　备案部门取消备案后，仍然使用该化妆品新原料生产化妆品或者仍然上市销售、进口该普通化妆品的，分别依照本条例第六十条、第六十一条的规定给予处罚。;处罚内容:2025年9月17日上午，我局执法人员根据广州市市场监督管理局关于依法查处广州市泉臣化妆品有限公司涉嫌违法案件的通知的线索，依法对位于广州市越秀区广园西路121号安华美博城主楼首层正门口左边自编A1号商铺的广州市泉臣化妆品有限公司的经营情况进行检查，并送达其在国产普通化妆品备案过程提交的篡改的检验报告（GF00132025339538）等资料，现场未发现经营涉案产品“张辉燕舒润液”及相关进销单据等，当事人现场签收相关资料，并表示对化妆品备案过程提交的虚假材料的违法行为无异议。本局已于当日立案，并进一步进行调查取证。经查明：当事人在涉案产品“张辉燕舒润液”（备案号：粤G妆网备字2025272080）的化妆品备案过程提交了篡改的检验报告（GF00132025339538）。2025年9月3日，“张辉燕舒润液”（备案号：粤G妆网备字2025272080）化妆品备案已被取消。根据当事人提供的材料，本局认定当事人委托生产上述涉案化妆品共10瓶，单价0.2元/瓶，进价2元，销售总额为0元；其中3瓶送备案检测，剩余7瓶被备案受托人王林菲私自销毁。库存0瓶，库存货值为0元。综上，当事人生产上述涉案化妆品货值金额2元，违法所得为0元。我局已依法于2025年12月30日向当事人送达《行政处罚告知书》，告知当事人享有的权利，当事人在法定期限内未行使陈述、申辩的权利。当事人在国产普通化妆品备案过程提交的篡改的检验报告的行为，违反了《化妆品监督管理条例》第十九条第三款的规定，构成了备案时提供虚假资料的违法行为。应当依据《化妆品监督管理条例》第六十五条第一款的规定给予行政处罚。当事人的违法行为不属于《广州市市场监督管理局关于印发广州市市场监管系统行政执法减免责清单（2025年）的通知》（穗市监规字〔2025〕3号）等减免清单中列明的可免处罚、减免责的情形。当事人积极配合本案调查，如实交代违法事实并主动提供证据材料，没有造成严重后果，依据《中华人民共和国行政处罚法》第五条第二款和《中华人民共和国行政处罚法》第二十八条第一款的规定，本局决定责令当事人改正国产普通化妆品备案时提供虚假资料的行为，并对当事人给予从轻处罚如下：罚款10000元。当事人应自收到本决定书之日起十五日内到银行缴纳罚款。逾期不缴纳，本局可以每日按罚款数额的百分之三加处罚款。如对本机关作出的处罚决定不服，可在收到文书之日起60日内向越秀区人民政府（受理地点：越秀区德安路1号之二3楼，电话：020-37634674）申请行政复议；或者在收到文书之日起6个月内直接向广州铁路运输法院（广州市番禺区石浦大道北33号，电话020-37890824）提起行政诉讼。违法行为类型:化妆品经营企业违法行为行政相对人名称:广州市泉臣化妆品有限公司行政相对人代码:统一社会信用代码组织机构代码工商登记码税务登记号事业单位证书号社会组织登记证号91440101MA59LATF3B法定代表人:郭晓南处罚决定日期:2026-01-12公示截止期:2026-04-12处罚机关:广州市越秀区市场监督管理局数据来源单位:广州市市场监督管理局（广州市知识产权局）

行政处罚相对人类别:法人及非法人组织行政处罚决定书文号:穗天市监处罚〔2026〕27号处罚类别:罚款罚款金额(万元):0.5没收违法所得、没收非法财物的金额(万元):暂扣或吊销证照名称及编号:违法事实:经查明，当事人于2025年8月4日向德国***化妆品有限公司进口涉诉产品“ARTDECO小滴管？白玫瑰浓缩精华持妆粉底液”，于2025年8月11日在其微信视频号平台“ARTDECO欧孚瑞店铺”涉诉产品详情页发布“是否孕妇可用孕妇可用…”及备案编号“国妆备进字J20135815”等内容。经查询国家药品监督管理局网站，国妆备进字J20135815备案编号对应的产品名称为雅蔻热辣丰唇蜜。经查涉诉产品实际备案编号为国妆网备进字（粤）2022000707，使用人群：03普通人群。当事人涉嫌对涉诉产品的性能、功能、质量等作虚假或引人误解商业宣传，欺骗、误导消费者。当事人分别于2025年9月23日、11月17日对其微信视频号“ARTDECO欧孚瑞店铺”涉诉产品详情页进行了整改，删除“孕妇可用”的描述，并更改备案编号为“国妆网备进字（粤）2022000707”。2025年8月11日至11月17日期间，当事人共销售涉案产品1件（已退货退款），单价520元/件，当事人对涉诉产品的性能、功能、质量等作虚假或引人误解商业宣传，欺骗、误导消费者违法行为货值金额为520元。处罚依据:根据《中华人民共和国反不正当竞争法（2025年修订）》第二十五条第一款“经营者违反本法第九条规定对其商品作虚假或者引人误解的商业宣传，或者通过组织虚假交易、虚假评价等方式帮助其他经营者进行虚假或者引人误解的商业宣传的，由监督检查部门责令停止违法行为，处一百万元以下的罚款；情节严重的，处一百万元以上二百万元以下的罚款，可以并处吊销营业执照。”的规定进行行政处罚。处罚内容:当事人对其商品的性能、功能、质量、销售状况、用户评价、曾获荣誉等作虚假或引人误解商业宣传，欺骗、误导消费者的行为涉嫌违反《中华人民共和国反不正当竞争法（2019年修订）》第八条第一款“经营者不得对其商品的性能、功能、质量、销售状况、用户评价、曾获荣誉等作虚假或者引人误解的商业宣传，欺骗、误导消费者。”的规定。当事人违法行为发生时间为2025年8至9月，违反《中华人民共和国反不正当竞争法（2019年修订）》第八条第一款的规定，依据《中华人民共和国反不正当竞争法（2019年修订）》第二十条第一款进行处罚。该法于2025年6月27日进行修订，新法自2025年10月15日起施行。对比现行立法《中华人民共和国反不正当竞争法（2025年修订）》，本案定性依据内容未修改（现行立法第九条第一款），处罚依据现行立法第二十五条第一款对当事人更有利。依据《行政处罚法》第三十七条“实施行政处罚，适用违法行为发生时的法律、法规、规章的规定。但是，作出行政处罚决定时，法律、法规、规章已被修改或者废止，且新的规定处罚较轻或者不认为是违法的，适用新的规定。”的规定，本案援引《中华人民共和国反不正当竞争法（2019年修订）》第八条第一款作为定性依据，援引《中华人民共和国反不正当竞争法（2025年修订）》第二十五条第一款作为处罚依据。鉴于当事人积极配合调查，如实交代违法事实并主动提供证据材料，货值金额较小，未发生严重危害后果，积极采取改正措施，其行为符合《广州市市场监督管理部门规范行政处罚自由裁量权规定》第十四条第（一）、（二）项所指“可以依法从轻行政处罚”情形。根据《中华人民共和国反不正当竞争法（2025年修订）》第二十五条第一款“经营者违反本法第九条规定对其商品作虚假或者引人误解的商业宣传，或者通过组织虚假交易、虚假评价等方式帮助其他经营者进行虚假或者引人误解的商业宣传的，由监督检查部门责令停止违法行为，处一百万元以下的罚款；情节严重的，处一百万元以上二百万元以下的罚款，可以并处吊销营业执照。”的规定，我局决定责令当事人立即停止对其商品的性能、功能、质量等作虚假或引人误解商业宣传，欺骗、误导消费者的行为，并对当事人作出以下从轻行政处罚：罚款5000元。违法行为类型:虚假宣传违法行为（虚假或引人误解的商业宣传）行政相对人名称:欧孚瑞(广州)化妆品有限公司行政相对人代码:统一社会信用代码组织机构代码工商登记码税务登记号事业单位证书号社会组织登记证号91440101MA5ATBYU5W法定代表人:吴泽鹏处罚决定日期:2026-01-09公示截止期:2026-04-09处罚机关:广州市天河区市场监督管理局数据来源单位:广州市市场监督管理局（广州市知识产权局）

行政处罚相对人类别:个体工商户行政处罚决定书文号:穗番市监处罚〔2026〕16号处罚类别:罚款罚款金额(万元):0.05没收违法所得、没收非法财物的金额(万元):暂扣或吊销证照名称及编号:违法事实:经查明，当事人在淘宝闪购上开设网店，名称为“娇兰佳人（番禺洛溪吉祥店）”，通过该网店销售“婷妹妹肌玻色因蕴能精华面酸10片/盒”等化妆品，在相关产品销售页面上未公示对应产品的注册、备案信息，或者上述信息的链接标识。当事人能提供对应产品的合法进货来源。处罚依据:《广东省化妆品安全条例》（2019年7月1日起施行）第五十九条：违反本条例第三十一条规定，化妆品电子商务经营者未在其网站显著位置公开其销售化妆品的注册备案信息，或者上述信息的链接标识的，由县级以上人民政府市场监督管理部门责令限期改正，可以处一万元以下罚款。;处罚内容:罚款500元违法行为类型:化妆品经营企业违法行为行政相对人名称:广州市番禺区洛浦阮吉化妆品店行政相对人代码:统一社会信用代码组织机构代码工商登记码税务登记号事业单位证书号社会组织登记证号92440101MA5AAHK03Q法定代表人:吴启明处罚决定日期:2026-01-09公示截止期:2026-04-09处罚机关:广州市番禺区市场监督管理局数据来源单位:广州市市场监督管理局（广州市知识产权局）

行政相对人名称牡丹江市爱民区天源大药房行政相对人代码(统一社会信用代码)91231004MA18YFEE6N法定代表人杜宝英行政处罚决定书文号牡市监处罚〔2026〕27号违法行为类型伪造、变造、出租、出借、非法买卖许可证或者药品批准证明文件的行为违法事实1、当事人未建立中药饮片的储存养护记录、购销记录，存在未按《药品经营质量管理规范》开展药品经营活动的行为；2、当事人将中药饮片的经营权租赁给张岐顺，存在出租《药品经营许可证》的行为；3、租赁费用为12000元，违法所得为12000元。处罚依据《中华人民共和国药品管理法（2019修订）》 / 第一百二十二条伪造、变造、出租、出借、非法买卖许可证或者药品批准证明文件的，没收违法所得，并处违法所得一倍以上五倍以下的罚款；情节严重的，并处违法所得五倍以上十五倍以下的罚款，吊销药品生产许可证、药品经营许可证、医疗机构制剂许可证或者药品批准证明文件，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，处二万元以上二十万元以下的罚款，十年内禁止从事药品生产经营活动，并可以由公安机关处五日以上十五日以下的拘留；违法所得不足十万元的，按十万元计算。;《中华人民共和国药品管理法（2019修订）》 / 第一百二十六条除本法另有规定的情形外，药品上市许可持有人、药品生产企业、药品经营企业、药物非临床安全性评价研究机构、药物临床试验机构等未遵守药品生产质量管理规范、药品经营质量管理规范、药物非临床研究质量管理规范、药物临床试验质量管理规范等的，责令限期改正，给予警告；逾期不改正的，处十万元以上五十万元以下的罚款；情节严重的，处五十万元以上二百万元以下的罚款，责令停产停业整顿直至吊销药品批准证明文件、药品生产许可证、药品经营许可证等，药物非临床安全性评价研究机构、药物临床试验机构等五年内不得开展药物非临床安全性评价研究、药物临床试验，对法定代表人、主要负责人、直接负责的主管人员和其他责任人员，没收违法行为发生期间自本单位所获收入，并处所获收入百分之十以上百分之五十以下的罚款，十年直至终身禁止从事药品生产经营等活动。处罚类别警告;罚款;没收违法所得处罚内容1、警告；2、没收违法所得：12000元；3、处罚款：12000元。罚款金额（万元）1.2没收违法所得没收非法财物的金额（万元）1.2处罚决定日期2026-01-13处罚有效期2099-12-01公示截止期2026-04-13处罚机关牡丹江市市场监督管理局

根据《宁夏回族自治区药品经营企业长期停业和恢复经营监督管理规定》（宁药监规发〔2025〕2号）相关要求，固原永寿堂医药有限公司向宁夏回族自治区药品监督管理局提交停业申请，企业承诺停业期间停止一切药品经营活动。企业在《药品经营许可证》有效期内恢复药品经营活动，需向宁夏回族自治区药品监督管理局提交书面报告，并经检查符合要求后方可恢复药品经营活动。现将企业信息予以通告。 附件：长期停业药品经营企业信息  宁夏回族自治区药品监督管理局2026年1月12日                  （此件公开发布）

行政相对人名称宝清县顺泰药品零售有限公司行政相对人代码(统一社会信用代码)91230523MA197FR32U法定代表人马健行政处罚决定书文号宝市监处罚〔2026〕3号违法行为类型未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的行为违法事实经查，当事人于2025年9月24日销售给举报人立普妥 阿托伐他汀钙片7盒、络活喜 苯磺酸氨氯地平片1盒、安达唐 达格列净2盒，共计收款580.00元。络活喜 苯磺酸氨氯地平片，批号8203932已提供随货同行单，立普妥 阿托伐他汀钙片7盒，批号8201558、8199632，是店员个人提供的（来源：店员父亲于北京看病时购买），无随货同行单。 至执法人员调查终结时，无消费者因服用当事人销售涉案药品产生的身体不良反应的反馈。 经询问当事人及查询国家企业信用信息公示系统，未发现当事人曾因非法渠道购进药品受过行政处罚。 经计算，当事人涉案药品货值金额共420.00元，违法所得共计420.00元。处罚依据《中华人民共和国药品管理法（2019修订）》 / 第一百二十九条违反本法规定，药品上市许可持有人、药品生产企业、药品经营企业或者医疗机构未从药品上市许可持有人或者具有药品生产、经营资格的企业购进药品的，责令改正，没收违法购进的药品和违法所得，并处违法购进药品货值金额二倍以上十倍以下的罚款；情节严重的，并处货值金额十倍以上三十倍以下的罚款，吊销药品批准证明文件、药品生产许可证、药品经营许可证或者医疗机构执业许可证；货值金额不足五万元的，按五万元计算。处罚类别罚款;没收违法所得处罚内容1、没收违法所得：420.00元（肆佰贰拾元整）； 2、罚款人民币：20000.00元（贰万元整）。罚款金额（万元）2没收违法所得没收非法财物的金额（万元）0.042处罚决定日期2026-01-13处罚有效期2099-12-01公示截止期2029-01-13处罚机关宝清县市场监督管理局