Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-25-114Product:DrugsRecipient:Katharine S. PersonPresident, CEO, and CFOPersōn & Covey, Inc.616 Allen AvenueGlendale,CA91021United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-114September 23, 2025Dear Ms. Person:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Persōn & Covey, Inc., FEI #2011222, located at 616 Allen Avenue, Glendale, CA 91021, from January 27 to February 6, 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, Xerac AC and Drysol drug products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a). Introducing, or delivering unapproved new drug products for introduction into interstate commerce is a violation under sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C., 331(d) and 355(a). These violations are described in more detail below.We reviewed your February 19, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your responses are inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).A. Your quality unit (QU) failed to adequately document and investigate multiple out-of-specification (OOS) results. Specifically, our inspection found that:Bulk Intermediate lot(b)(4), Xerac AC, failed the active ingredient content (Aluminum Chloride Hexahydrate) test four times prior to release for further processing, using the(b)(4)Spectrophotometer. You released the material after the(b)(4)sample obtained a passing result, which was the only test result attributed to bulk lot(b)(4). The initial(b)(4)test results were disregarded and not investigated by your QU.The inspection documented that “System Administrator” was the only user type attributable in the(b)(4)Software and laboratory personnel shared a common password for the Windows and(b)(4)software systems. Also, audit trails are not independently reviewed after analysis or at an established frequency; and there is no review of the electronic raw data or printed hard copy data.In your response, you indicate that “There was never a formal procedure for Data Integrity” and you commit to developing one. Your response is inadequate. Your response did not include an assessment or commitment to determine the extent of documentation deficiencies throughout your firm and impact to the safety, effectiveness, and quality of the drug products you continue to manufacture.Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance 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.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 drugs distributed in 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 microbiological and analytical data, manufacturing records, and all data submitted to FDA.B. Appropriate procedures are not followed by your QU to ensure adequate oversight.On November 18, 2021, both your Quality Assurance (QA) and Quality Control (QC) units approved the disposition of Solbar Zinc Sunscreen finished batch(b)(4)for destruction due to a high pH result of the finished drug product. However, this batch was reworked in March 2022 without a pre-approved rework protocol, as required by your procedure. The rework conducted was not contemporaneously documented. The inspection also documented that a batch record for the reworked Solbar Zinc Sunscreen batch was not generated. Instead, QC management issued an internal memo post-processing that lacked the following: lot number of the additional components added, specific equipment used to rework the batch, mixing speed and duration, description and lot number of final container, weight and yield of the reworked batch, additional processing time, sampling details, number of pieces filled, and the assigned expiry date.After the batch was released, QC management distributed an email identifying the date of release, the container size, and the number of pieces released. The inspection documented that the QA management was not involved in the decision to revert the disposition of batch(b)(4)from destruction to rework.In your response, you acknowledge the observation and commit to redefining roles, responsibilities, and the authority of your QU. However, your response is inadequate because you do not commit to conduct an in-depth investigation into the redisposition, rework, and release of batch(b)(4)and other batches that may have been released without documented QU approval.In response to this letter, provide:A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively exercise its responsibility. The assessment should also include, but not be limited to:o A determination of whether procedures used by your firm are robust and appropriate.o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.o A complete and final review of each batch and its related information before the QU disposition decision.o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all drug products.o Describe how top management supports quality assurance and reliable operations, including but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).Three over the counter (OTC) drug products: Solbar Zinc Sunscreen, DHS Zinc Shampoo, and DHS Tar Shampoo failed to meet pre-defined quality attributes at multiple timepoints during long-term room temperature storage conditions. A timely and thorough investigation into the root causes of the OOS events was not performed.Multiple high pH failures in Solbar Zinc Sunscreen long-term stability studies were investigated in OOS No. 14. The scope of the investigation included four failed stability intervals for batch(b)(4)(e.g.,(b)(4)) and two failures for batch(b)(4)(e.g.,(b)(4)and(b)(4)). Although the Phase I investigation did not identify any discrepancies in test performance, it does not specify which of the collective six failed timepoints was the subject of the laboratory observation. Retains for the final timepoints for each batch were retested confirming the initial failure but retains from four unrelated batches were also tested to demonstrate that the “…issue comes from the formulation of the product.” The OOS template question of whether a Phase II investigation was required was not completed and remained unanswered.The OOS investigation into DHS Zinc Shampoo batch(b)(4)stability failures identified what appeared to be a trend, concluding “it seems that the pH goes above range … For lot(b)(4)at all temperatures … at all months … are above range.” The Summary of Investigation concludes that “Further investigation into product is needed.” However, the OOS template question of whether a Phase II investigation was required was answered, indicating that “No” Phase II investigation was needed.The Phase I OOS investigations into coal tar content failures (DHS Tar Shampoo batches(b)(4), and(b)(4)) failed to identify relevant root cause. Assay suitability was suggested as a potential root cause but was rejected by QC management without further investigation into either the validity of the assay results or a Phase II investigation.Despite the inconclusive Phase I investigations and documented recognition of trending, OOS investigations were repeatedly closed without completion of a Phase II investigation. The Phase I investigations were approved by the Chief Compliance Officer as mandated by procedure “*Only if Phase II investigation isn’t required.” These drug products are currently on the market and within expiry.Your response is inadequate. You assert that “The discrepancies have been addressed either by Non-Conformance, OOS, or a Deviation by the QA team.” A possible laboratory error is insufficient to close an investigation at Phase I. Whenever an investigation lacks conclusive evidence of laboratory error, a thorough investigation of potential manufacturing causes must be performed. For more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigating-out-specification-oos-test-results-pharmaceutical-production-level-2-revision.In response to this letter, provide:A retrospective, independent review of all invalidated OOS (including in-process and release / stability testing) results for drug products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS:o Determine whether the scientific justification and evidence relating to the invalidated OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.Also, provide a comprehensive review and remediation plan for your OOS result investigation systems. The corrective action and preventive action should include, but not be limited to, addressing the following:o QU oversight of laboratory investigations.o Identification of adverse laboratory control trends.o Resolution of causes of laboratory variation.o Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identified.o Adequately scoping of each investigation and its CAPA.o Revised OOS investigation procedures with these and other remediationsIn response to this letter provide an action plan to address any drug product quality or patient safety risks for all batches of OTC drug products in U.S. distribution, including potential customer notifications and recalls or market withdrawals.3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Changes to the formulations of OTC drug products DHS Tar Shampoo and DHS Zinc Shampoo, including the introduction of different inactive ingredients, were made without demonstrating you have a reproducible commercial manufacturing process, or documented evidence that the reformulated drug products will consistently meet their quality attributes throughout shelf-life. The drug products were reformulated between July 2013 and May 2018 without execution of process validation and demonstration of acceptable stability data to establish expiry. Process validations for both drug products were last executed in 1999. The inspection documented similar changes to the Solbar Zinc Sunscreen formulation during the same timeframe, also without process validation and stability data. Process Validation for Solbar Zinc Sunscreen was last performed in 2002.Subsequent to drug product reformulation, the OOS failures referenced in(b)(4)above, were detected during long-term room temperature stability studies for all three OTC drug products. Modifications to the manufacturing processing parameters for Solbar Zinc Sunscreen batch(b)(4)(April 2023) and DHS Tar Shampoo batch(b)(4)(November 2023) were handwritten comments changing the sequencing of steps, equipment used, temperatures, durations, quantities, and volumes without justification. In August of 2023, your firm implemented a Product Adjustment Form (QCF-068) to document “routine” in-process manufacturing changes made by Quality Control. OOS Investigation No. 14 noted in November 2024 that a likely factor in Solbar Zinc Sunscreen long-term stability pH failures could be “that the Manufacturing process for Solbar Zinc is constantly changing...”Your response is inadequate because your CAPA commits to implementing consultant expert opinions and suggestions that you have been in possession of as early as 2022. You failed to implement meaningful corrective actions, interim measures, or to provide an action plan to address any drug product quality or patient safety risks for all batches of OTC drug products in U.S. distribution, including potential customer notifications and recalls or market withdrawals. Further, you ceased to enroll representative batches of Solbar Zinc Sunscreen or DHS Tar Shampoo in annual stability studies in 2024 and DHS Zinc Shampoo in 2023 and 2024 to continue monitoring drug product quality.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the drug product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing appropriate PPQ for each of your marketed drug products.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 comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each drug product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).All procedures that describe these and other elements of your remediated stability program.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Unapproved New DrugsXerac AC and Drysol products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.Examples of claims, from labeling from your firm’s website and labeling submitted to the electronic Drug Registration and Listing System, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of your drug products include, but may not be limited to, the following:Xerac ACIntended for topical application as an antiperspirant (anhidrotic) for patients suffering from hyperhidrosis, or patients whose jobs or sports activities cause excessive sweating that exacerbates other skin problems.DrysolIntended for severe hyperhidrosis.Your drug products Xerac AC and Drysol are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for your drug products. Accordingly, these drug products are unapproved new drugs marketed in violation of sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).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 2011222 and ATTN: Kara S. Quinn.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Brad Pace, J.D.Associate DirectorOffice of Unapproved Drugs and Labeling ComplianceSigned on behalf of:Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and Research

近日，我省获批开展优化药品补充申请审评审批程序改革试点。省内企业积极响应，首批已有2家企业通过前置服务平台申报哌拉西林、他唑巴坦2个品种重大变更补充申请。根据省药监局统一部署，省药品认证审评中心作为负责改革试点的专门机构，按照“提前介入、一企一策、全程指导、研审联动”原则，迅速启动相关药品补充申请的前置服务工作，对申报产品开展前置指导。收到企业申报资料后，第一时间组织审评人员开展资料审查，依程序确定是否启动前置核查、前置检验，并指导企业完善申报资料。此举标志着江西省药品补充申请试点工作拉开帷幕，为全省药品上市后重大变更补充申请审评审批按下“加速键”。下一步，省药品认证审评中心将以开展优化药品补充申请审评审批程序改革试点工作为契机，持续加强政策宣贯，提升江西省药品审评服务能力，推动江西省更多药品补充申请进入改革试点通道，高质量开展前置服务工作，助力全省医药产业高质量发展。（省药品认证审评中心供稿）

根据《化妆品监督管理条例》《化妆品注册备案管理办法》和《国家药监局关于实施〈化妆品注册备案资料管理规定〉有关事项的公告》（2021年第35号）等规定，自2022年1月1日起，通过原注册备案平台和新注册备案平台备案的普通化妆品，统一实施年度报告制度。备案人应当于每年1月1日至3月31日期间，通过新注册备案平台，提交备案时间满一年普通化妆品的年度报告。部分化妆品备案人未履行法定年度报告义务，且未按要求在规定期限内改正，其行为违反了《化妆品注册备案管理办法》第三十七条第一款之规定，我局拟依据《化妆品注册备案管理办法》第五十九条第（二）项之规定，依法取消其普通化妆品备案（产品清单见附件1）。对取消备案产品有异议的化妆品备案人，请于本公告发布后15个工作日内，携带有效市场主体登记证明（《营业执照》等）复印件、《普通化妆品取消备案申辩书》（模板见附件2）向河北省药品监督管理局提出陈述和申辩（受理地址：河北省石家庄市桥西区南二环西路45号，电话：0311-83720195）。逾期未提出的，视为放弃陈述和申辩的权利。逾期未提出陈述和申辩，或经依法审核异议未被采纳的，将取消相关普通化妆品备案。特此公告。附件：1.河北省拟取消普通化妆品备案产品清单河北省药品监督管理局2025年9月30日河北省拟取消普通化妆品备案产品清单产品名称备案编号企业名称朵羚维生素 E 乳冀G妆网备字2023000396沧州天娇商贸有限公司凝华CODENCE焕颜水冀G妆网备字2023000122河北华悦美容服务有限公司凝华CODENCE臻彩焕颜水冀G妆网备字2023000121河北华悦美容服务有限公司凝华草本精华液冀G妆网备字2018000998河北华悦美容服务有限公司凝华水润清透洁面乳冀G妆网备字2021500157河北华悦美容服务有限公司SAIWELA 棉花糖系列甲油胶冀G妆网备字2022001932河北甲睫作商贸有限公司SAIWELA巧克力系列甲油胶冀G妆网备字2022001930河北甲睫作商贸有限公司SAIWELA 圣薇澜甲油胶冀G妆网备字2021500335河北甲睫作商贸有限公司SAIWELA 樱花腮红系列甲油胶冀G妆网备字2022001931河北甲睫作商贸有限公司丹吉雅搓泥浴宝去角质啫喱膏冀G妆网备字2021500439河北三辉日用化妆品有限公司丹吉雅玫瑰浴盐冀G妆网备字2023001270河北三辉日用化妆品有限公司丹吉雅牛奶润肤乳冀G妆网备字2023001300河北三辉日用化妆品有限公司丹吉雅薰衣草浴盐冀G妆网备字2023001299河北三辉日用化妆品有限公司朵芬娜牛奶浴盐冀G妆网备字2023001298河北三辉日用化妆品有限公司朵芬娜水蜜桃搓泥去角质啫喱冀G妆网备字2023001629河北三辉日用化妆品有限公司蓝黛圣菲补水精华液冀G妆网备字2023001365河北三辉日用化妆品有限公司蓝黛圣菲蚕丝乳冀G妆网备字2023001363河北三辉日用化妆品有限公司蓝黛圣菲蚕丝水润体膜冀G妆网备字2023001362河北三辉日用化妆品有限公司蓝黛圣菲蚕丝体膜冀G妆网备字2023001374河北三辉日用化妆品有限公司蓝黛圣菲搓泥浴宝去角质啫喱膏冀G妆网备字2021500440河北三辉日用化妆品有限公司蓝黛圣菲蜂蜜精华液冀G妆网备字2023001357河北三辉日用化妆品有限公司蓝黛圣菲蜂蜜牛奶蚕丝乳冀G妆网备字2023001321河北三辉日用化妆品有限公司蓝黛圣菲海藻面膜冀G妆网备字2023001375河北三辉日用化妆品有限公司蓝黛圣菲海藻面膜专用水冀G妆网备字2023001376河北三辉日用化妆品有限公司蓝黛圣菲火山泥面膜冀G妆网备字2023001378河北三辉日用化妆品有限公司蓝黛圣菲芦荟搓泥去角质啫喱冀G妆网备字2023001356河北三辉日用化妆品有限公司蓝黛圣菲芦荟精华液冀G妆网备字2023001360河北三辉日用化妆品有限公司蓝黛圣菲芦荟牛奶蚕丝乳冀G妆网备字2023001322河北三辉日用化妆品有限公司蓝黛圣菲玫瑰搓泥去角质啫喱冀G妆网备字2023001323河北三辉日用化妆品有限公司蓝黛圣菲玫瑰精华液冀G妆网备字2023001359河北三辉日用化妆品有限公司蓝黛圣菲玫瑰精油冀G妆网备字2023001377河北三辉日用化妆品有限公司蓝黛圣菲玫瑰牛奶蚕丝乳冀G妆网备字2023001319河北三辉日用化妆品有限公司蓝黛圣菲免洗面部精华液冀G妆网备字2023001370河北三辉日用化妆品有限公司蓝黛圣菲木瓜精华液冀G妆网备字2023001366河北三辉日用化妆品有限公司蓝黛圣菲牛奶润肤乳冀G妆网备字2023001358河北三辉日用化妆品有限公司蓝黛圣菲青瓜精华液冀G妆网备字2023001361河北三辉日用化妆品有限公司蓝黛圣菲青瓜牛奶蚕丝乳冀G妆网备字2023001318河北三辉日用化妆品有限公司蓝黛圣菲软黄金体膜冀G妆网备字2023001371河北三辉日用化妆品有限公司蓝黛圣菲石榴精华液冀G妆网备字2023001368河北三辉日用化妆品有限公司蓝黛圣菲水蜜桃搓泥去角质啫喱冀G妆网备字2023001324河北三辉日用化妆品有限公司蓝黛圣菲透明质酸钠精华液冀G妆网备字2023001369河北三辉日用化妆品有限公司蓝黛圣菲蜗牛精华液冀G妆网备字2023001372河北三辉日用化妆品有限公司蓝黛圣菲香体盐冀G妆网备字2023001364河北三辉日用化妆品有限公司如水若泉补水精华液冀G妆网备字2023000814河北三辉日用化妆品有限公司如水若泉蚕丝乳冀G妆网备字2023000787河北三辉日用化妆品有限公司如水若泉蚕丝体膜冀G妆网备字2023000832河北三辉日用化妆品有限公司如水若泉发膜冀G妆网备字2023000831河北三辉日用化妆品有限公司如水若泉蜂蜜精华液冀G妆网备字2023000398河北三辉日用化妆品有限公司如水若泉火山泥面膜冀G妆网备字2023000830河北三辉日用化妆品有限公司如水若泉芦荟精华液冀G妆网备字2023000487河北三辉日用化妆品有限公司如水若泉芦荟香浴盐冀G妆网备字2021500441河北三辉日用化妆品有限公司如水若泉玫瑰搓泥去角质啫喱冀G妆网备字2023001628河北三辉日用化妆品有限公司如水若泉玫瑰精华液冀G妆网备字2023000747河北三辉日用化妆品有限公司如水若泉牛奶蚕丝水润体膜冀G妆网备字2023000813河北三辉日用化妆品有限公司如水若泉牛奶润肤乳液冀G妆网备字2023000829河北三辉日用化妆品有限公司如水若泉牛奶香浴盐冀G妆网备字2023000815河北三辉日用化妆品有限公司如水若泉青瓜精华液冀G妆网备字2023000486河北三辉日用化妆品有限公司如水若泉软黄金体膜冀G妆网备字2023000828河北三辉日用化妆品有限公司如水若泉水蜜桃搓泥去角质啫喱冀G妆网备字2023001425河北三辉日用化妆品有限公司如水若泉透明质酸钠精华液冀G妆网备字2023000827河北三辉日用化妆品有限公司如水若泉香体盐冀G妆网备字2023000816河北三辉日用化妆品有限公司岚玉荷洗手液冀G妆网备字2023001274石家庄祥腾日化有限公司Shang Aimei Rejuvenating & Moisturizing Essence国妆网备出字（冀）2022000001河北京鼎生物医药科技有限公司Shang Aimei Rejuvenating & Moisturizing Toner国妆网备出字（冀）2022000002河北京鼎生物医药科技有限公司Shang Aimei Reiuvenating & Moisturizing Lotion国妆网备出字（冀）2022000003河北京鼎生物医药科技有限公司Shang Aimei NMN Caviar Moisturizing Essence国妆网备出字（冀）2022000004河北京鼎生物医药科技有限公司Shang Aimei Intensive hydrating Lotion国妆网备出字（冀）2022000006河北京鼎生物医药科技有限公司Shang Aimei Intensive hydrating Essence国妆网备出字（冀）2022000007河北京鼎生物医药科技有限公司Shang Aimei NMN Caviar Moisturizing Essence Cream国妆网备出字（冀）2022000008河北京鼎生物医药科技有限公司Shang Aimei EGF Anti-Aging Cream国妆网备出字（冀）2022000009河北京鼎生物医药科技有限公司Shang Aimei EGF Anti-Aging Essence国妆网备出字（冀）2022000010河北京鼎生物医药科技有限公司Shang Aimei Anti-Wrinkle Firming Eye Cream国妆网备出字（冀）2022000011河北京鼎生物医药科技有限公司SUMEDHA施美达碳酸面膜国妆网备进字（冀）2020000022石家庄健洛特网络科技有限公司

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桂药监流稽罚〔2025〕7号广西梧州市杰迅医药有限公司销售劣药红参（红参片）案广西梧州市杰迅医药有限公司91450400756533878X王静宇当事人经营劣药红参（红参片）（批号：202412001）的行为，违反了《中华人民共和国药品管理法》第九十八条第一款的规定依据《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国行政处罚法》第二十八条第一款、《中华人民共和国药品管理法实施条例》第七十五条的规定，责令当事人立即改正上述违法行为，并给予以下行政处罚：主动履行；主动履行期限2025年8月6日广西壮族自治区药品监督管理局；2025/07/221.没收劣药6.497kg；2.没收违法所得1766.4元（壹仟柒佰陆拾陆元肆角）

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桂药监梧分罚〔2025〕2号广西梧州市杰迅医药有限公司经营劣药柴胡（北柴胡）（批号：240501）案广西梧州市杰迅医药有限公司91450400756533878X王静宇广西梧州市杰迅医药有限公司销售的柴胡（北柴胡）（上市许可持有人：安徽益晟堂制药有限公司；生产单位：安徽益晟堂制药有限公司；批号：240501；规格：中药饮片；包装规格：0.5kg/袋）于2025年4月9日经梧州市食品药品检验所抽检，于2025年5月15日经梧州市食品药品检验所检验，【性状】项不符合规定。经查，当事人于2024年9月3日至2025年2月11日期间，分三次向安徽益晟堂制药有限公司购进柴胡（北柴胡）40kg，购进金额为7025.00元，违法所得合计为9197.50元。依据《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国行政处罚法》第二十八条第一款、《中华人民共和国药品管理法实施条例》第七十五条的规定，责令当事人立即改正上述违法行为，并给予没收销售劣药柴胡（北柴胡）（批号：240501）的违法所得人民币9197.50元（玖仟壹佰玖拾柒元伍角整），免除其他行政处罚。主动履行广西壮族自治区药品监督管理局2025年9月19日

浙江一方制药有限公司在我局组织的监督检查中，因不符合药品GMP要求，被我局采取暂停生产、销售药品的风险控制措施。企业在完成缺陷项目的整改后，向我局提出解除风险控制措施的申请，经现场检查，确认企业已完成整改。依据《药品生产监督管理办法》第五十九条第三款的规定，同意解除暂停生产、销售药品的风险控制措施。特此通告。浙江省药品监督管理局2025年9月30日

根据《中华人民共和国行政许可法》《中华人民共和国药品管理法》和《药品经营和使用质量监督管理办法》等相关规定及企业申请，经我局研究决定，依法注销河北机械进出口有限公司《药品经营许可证》。特此公告。附件：河北省《药品经营许可证》注销名单河北省药品监督管理局2025年9月30日企业名称经营方式许可证编号法定代表人企业负责人质量负责人经营范围河北机械进出口有限公司批发（法人）冀AA3110166欧建军杜建光梁运川中成药、化学药制剂、抗生素制剂、生化药品、生物制品、蛋白同化制剂、肽类激素*(仅限以上药品直接进出口及销售、援外)

依据年度抽检工作计划安排，江苏省药品监督管理局组织对部分药品生产、经营、使用单位进行了抽检。现将抽检中发现的6批次不符合规定药品信息予以通告（详见附件）。对不符合规定的药品，我省各级药品监督管理部门已要求相关企业和单位采取暂停销售、使用等风险控制措施，对不符合规定原因开展调查并切实进行整改。对不符合规定的药品，监管部门已依法组织开展对相关企业和单位的查处。附件：6批次不符合规定药品信息江苏省药品监督管理局2025年9月30日

行政相对人名称 南通昌盛医用材料有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91320682714135812L 工商注册号 组织机构代码 税务登记号 事业单位证书号 社会组织登记证号 法定代表人 朱从国 法定代表人证件类型 法定代表人证件号码 证件类型 证件号码 行政处罚决定书文号 苏药监通处罚〔2025〕2号 违法行为类型 生产销售不符合经注册的产品技术要求的医疗器械 违法事实 南通昌盛医用材料有限公司涉嫌生产不符合经注册的产品技术要求的医疗器械。该公司的上述行为涉嫌违反了《医疗器械监督管理条例》第三十五条“……，保证出厂的医疗器械符合强制性标准以及经注册或者备案的产品技术要求”的规定，建议予以立案调查。 处罚依据 《医疗器械监督管理条例》第八十六条第（一）项 处罚类别 罚款;没收违法所得、没收非法财物 处罚内容 1．没收违法所得6303元。 2．并处罚款21000元。（以上罚没合计人民币27303元） 罚款金额（万元） 2.100000 没收违法所得没收非法财物的金额（万元） 0.630300 暂扣或吊销证照名称及编号 处罚决定日期 2025/09/30 处罚有效期 2025/10/15 公示截止期 2028/09/30 处罚机关 江苏省药品监督管理局 处罚机关统一社会信用代码 11320000014000394R 数据来源单位 江苏省药品监督管理局 数据来源单位统一社会信用代码 11320000014000394R 备注 公示截止期依据文件：市场监督管理行政处罚信息公示规定