Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Hale N. DimetryPresidentPQ Pharmacy, LLC15215 Technology DriveBrooksville,FL34604-0690United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 715795October 10, 2025Dear Mr. Dimetry:You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]1on October 29, 2020, and most recently on November 26, 2024. From March 25, 2025, to April 4, 2025, an FDA investigator inspected your facility, PQ Pharmacy, LLC, located at 15215 Technology Drive, Brooksville, FL 34604. During the inspection, the investigator noted that drug products you produced failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. In addition, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.FDA issued a Form FDA 483 to your facility on April 4, 2025. FDA acknowledges receipt of your facility’s response, dated April 7, 2025. Based on this inspection, it appears you produced drugs that violate the FDCA.A. Compounded Drug Products under the FDCAUnder section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.2An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.In addition, for a compounded drug product to qualify for the exemptions under section 503B, the labeling of the drug must include certain information (section 503B(a)(10) of the FDCA [21 U.S.C. §353b(a)(10)]).Furthermore, for a compounded drug product to qualify for the exemptions under section 503B, it must be compounded in an outsourcing facility that is in compliance with the registration and reporting requirements in section 503B(b), including the requirement to submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations)” (section 503B(a)(1), (b)(5) of the FDCA [21 U.S.C. § 353b(a)(1), (b)(5)]).B. Failure to Meet the Conditions of Section 503BDuring the inspection, the FDA investigator collected evidence indicating that drug products produced by your facility failed to meet the conditions of section 503B. For example, the investigator collected evidence indicating that:1. Some of your facility’s drug products, such as Prednisolone/Moxifloxacin HCl/Bromfenac PF Sterile Ophthalmic Solution and Prednisolone/Moxifloxacin HCl PF Sterile Ophthalmic Solution, did not include the established name of the drug.2. Your facility did not submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, CFR (or any successor regulations).3 Specifically, your facility’s procedures for reporting adverse events are inadequate. For example, your documented procedures for reporting adverse events do not include the following information in the definition of what constitutes a “serious” adverse event: “Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.” (21 CFR 310.305(b)).Because your compounded drug products have not met all of the conditions of section 503B, they are not eligible for the exemptions in that section from the FDA approval requirements of section 505, the requirement under section 502(f)(1) that labeling bear adequate directions for use, and the Drug Supply Chain Security Act requirements described in section 582 of the FDCA.Specific violations are described below.C. Violations of the FDCAAdulterated Drug ProductsThe FDA investigator 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 investigator observed that:1. An operator rested their arms on the work surface of the hood during aseptic production. This practice may introduce contamination into the ISO(b)(4)work area.2. Operators conducted aseptic manipulations in an area where the movement of “first air” in the ISO(b)(4)area was disrupted by operator manipulations, including the failure to limit unnecessary movement and make mindful, slow, deliberate movements within the ISO(b)(4)laminar flow hoods and within the ISO(b)(4)cleanroom suite.3. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO(b)(4)area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.The FDA investigator also noted CGMP violations at your facility that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:1. 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)).2. Your firm failed to 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 (21 CFR 211.113(b)).3. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).4. 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).Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance,Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.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.Unapproved New Drug ProductsYou do not have any FDA-approved applications on file for drug products that you compound.4Under sections 505(a) and 301(d) of the FDCA [21 U.S.C. §§ 331(d)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FDCA is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.Misbranded Drug ProductsYou compound drug products that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FDCA.5The introduction or delivery for introduction into interstate commerce of these products therefore violates section 301(a) of the FDCA. Further, 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.D. Corrective ActionsWe have reviewed your facility’s response to the Form FDA 483. Some of your corrective actions appear adequate; however, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:1. You did not provide scientific justification for the selection of(b)(4)intensity to conduct visual inspection for all sterile products.2. You did not provide training records and personnel qualification records for procedure S203005.3 Qualification of Personnel for Particulate and Defect Inspection Activities.Some of your corrective actions appear deficient:1. Regarding your failure to conduct hold time studies, we note that you have provided methods, such as media fill runs, to mitigate certain risks; however, these measures alone are insufficient. A hold time study remains necessary to evaluate container closures of the bulk holding material, testing of the bulk material being held prior to further processing, potential risk associated with sterility, contamination, product degradation, adsorption, or absorption. Furthermore, you failed to establish adequate written procedures for production and process controls, including but not limited to the following:a. Hold time studies to justify your(b)(4)-day holding of bulk product.b. Hold time studies to include the impact of an additional(b)(4)step, particularly in cases where such steps are used to extend the bulk hold period beyond the initial(b)(4)-days.c. Process validation, to include your(b)(4)step following detection of particulates or to provide a scientific study justifying this step. Moreover, you failed to define when an investigation is warranted in the event a product requires(b)(4). For example, your standard operating procedures do not mandate a root cause investigation in cases of(b)(4)failure or particulate observation beyond initiating a deviation. Additionally, your classification of deviations, such as “Critical Deviation,” does not include the definition for(b)(4)resulting from(b)(4)failures(b)(4).2. Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. More specifically, you failed to expand your investigations into other products using the same lots of affected material (i.e. bulk bags, syringes, or(b)(4)). Although you state that a review was conducted, the deviation report does not include a list of the specific lots that were assessed. Relying solely on trending data is not sufficient to justify the scope of an investigation.a. Regarding the(b)(4)of the bulk solution bag, your response fails to clarify whether your(b)(4)process has been validated for repeat(b)(4)procedures. While your firm has identified the likely root cause of deviation DEV2024072 as intrinsic to the interior of the bulk bag, your response does not demonstrate that you have conducted adequate analysis beyond verifying expiration dates. Furthermore, there is no evidence that you examined other products manufactured using the same lot of bulk bags that produced the contaminated material, nor did you conduct additional review of retained samples that could provide valuable insight into the scope of this issue. Moreover, you did not investigate the integrity of the bags’ material nor conduct further investigation including communicating with the manufacturer. In addition, particulate testing appears to have been conducted only after the repeated(b)(4), which raises concerns that the nature and extent of the contamination were not being appropriately characterized.b. Regarding your failure to follow-up on the root cause determination of DEV2024075, numerous critical deficiencies remain unaddressed and require comprehensive corrective and preventative actions. Your investigation does not include an adequate root cause analysis as you failed to review other products using the same lot of syringes, conduct any review of retained samples, or provide identification and characterization of the particulates to determine how they differed from the 19 rejects identified during 100% visual inspection. Additionally, your response does not address whether you investigated the integrity of the syringes themselves or notified the syringe manufacturer or distributor of this potential component-related issue.c. You failed to follow-up your root cause determination of DEV2023007 related to the sterile(b)(4). Additionally, you did not conduct process validation for the change involving the flushing and discarding of the first(b)(4)or(b)(4)mL of product (depending on the product). You also conducted no further investigation into the(b)(4)issue, including communication with the manufacturer.d. Your conclusion that post-bulk fill contamination was addressed through(b)(4)does not identify the original source of the contamination.Additionally, you provided no assessment or strategy to prevent further(b)(4)contamination from reoccurring.e. You did not provide a risk analysis of the products produced during the observed poor aseptic practices, nor was this analysis extended to other drug products produced on the same days. Disposition was also not provided for the following products, including whether they were released or distributed:ProductLot numberProduction datePrednisolone Sodium Phosphate/Moxifloxacin HCl/Bromfenac PFPMB032025NFG3/26/2025Prednisolone Sodium Phosphate/Moxifloxacin HCl/Bromfenac PFPMB032025NFG1 (5.6mL)3/28/2025Prednisolone Sodium Phosphate/Moxifloxacin HCl/Bromfenac PFPMB032025EO1 (8.6mL)3/28/2025Semaglutide 5mg vialsSEM032525JP3/28/20253. Your smoke studies remain inadequate to demonstrate proper unidirectional airflow within the ISO(b)(4)area. While we acknowledge that your smoke studies now include dynamic studies mimicking the operations of capping and crimping, these studies reveal airflow deficiencies that could compromise aseptic operations. Specifically, video 4(b)(4)Static shows from time 0:59 to 1:37 the smoke arching past multiple rows of vials as it exits the front of the hood, indicating disrupted laminar flow that could transport contaminants across the work surface. Additionally, multiple objects such as the sampling plates and the sampler, are placed in front of the ventilation at the back of the hood, creating physical barriers that disrupt the intended unidirectional airflow pattern.In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products.Seesection 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]Should you continue to compound and distribute drug products that do not meet the conditions of section 503B, the compounding and distribution of your drugs would be subject to the new drug approval requirement, the requirement to label drug products with adequate directions for use, and the Drug Supply Chain Security Act requirements.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.E. 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 that 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 within which you will do so.All correspondence should refer to the Warning Letter Number above (# 715795) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.Sincerely,/S/F. Gail Bormel, JD, RPhDirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Research________________________1See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).2We remind you that there are conditions, other than those discussed in this letter, that must be satisfied to qualify for the exemptions in section 503B of the FDCA.3For more information, see, FDA’s guidance, “Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” which can be found at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM434188.pdf.4The specific products made by your firm are drugs within the meaning of section 201(g) of the FDCA [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FDCA [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.5Your compounded drug products are not exempted from the requirements of section 502(f)(1) of the FDCA by regulations issued by the FDA (see, e.g., 21 CFR 201.115).

安徽省中药饮片（含中药配方颗粒）生产第二分局日常监督检查信息通告（2025年11月）.xls

医保基金作为人民群众的“看病钱”“救命钱”，绝不容许任何形式的侵占、挪用与骗取。为进一步强化全民医保法治意识、深化警示教育效果，巩固对欺诈骗保行为的高压态势，彰显守护医保基金安全的坚决态度，国家医保局现发布第四期5起个人骗取医保基金典型案例。案例一河北省秦皇岛市关某等5人冒名就医和倒卖医保药品骗保案2025年1月，河北省秦皇岛市医保部门收到相关部门移交的线索后，立即会同秦皇岛市港航公安机关开展联合调查。经查，2023年2月至2024年12月，参保人关某为获取非法利益，通过刘某、孟某某、贾某某、玄某某收集社会保障卡70余张，关某利用收集的这些社会保障卡，以代购药名义先后在秦皇岛市21家医疗机构开具司美格鲁肽并骗取医保基金报销12万余元。随后，关某将购买的这些司美格鲁肽，通过邮寄方式向湖北省武汉市、河南省开封市、天津市等地销售获利。2025年5月13日，港航公安局将关某、刘某、孟某某、贾某某、玄某某5名犯罪嫌疑人移送海港区人民检察院审查起诉。目前，案件正在海港区人民检察院审查起诉中。经查，关某为公职人员，2025年5月26日已将关某案件同步移送秦皇岛市纪检监察机关。案例二安徽省芜湖市参保人肖某倒卖医保药品骗保案2024年8月，安徽省芜湖市医保局收到举报线索，反映参保人肖某涉嫌利用享受低保人员医保待遇倒卖医保药品。当地医保部门立即联合公安机关开展深入研判和调查。经查，肖某患有“肝豆状核变性”疾病，需要常年服用药物治疗。2022年2月至2024年3月，肖某在合肥市异地就医期间，为获取非法利益，隐瞒自己实际药品需求量，骗取多名医生开具治疗“肝豆状核变性”的青霉胺、奥拉西坦片、肝豆片等药品，肖某除留足自己需要服用的药品外，通过微信等方式线上联系买家，将多开的药品通过快递邮寄方式出售，共骗取医保基金51950.91元。2025年7月，芜湖市南陵县人民法院依法判决肖某犯诈骗罪，判处有期徒刑3年，缓刑3年，并处罚金人民币20000元，同时责令全额退赔骗取的医保基金。案例三河南省郑州市参保人张某伪造证明材料骗保案2024年1月，河南省郑州市医保局巩义分局在对意外伤害医疗费用核查时，发现参保人张某《住院病历》记录的受伤经过与《外伤无第三方责任承诺书》记录的受伤经过不一致，于是迅速组织力量开展调查核实。经查，张某于2023年6月在其受雇公司工作时意外坠落受伤，并已接受该公司相关赔偿，不符合医保报销条件。2023年8月，张某出院时为非法获利，伙同妻子潘某谎称因下楼梯时不小心摔伤并签订《外伤无第三方责任承诺书》，伪造无第三方责任相关证明材料，共骗取医保报销费用39477.26元。郑州市医保局巩义分局依法追回损失的医保基金39477.26元，并将案件线索移送当地公安机关。2024年4月，巩义市人民法院判决张某犯诈骗罪，判处有期徒刑2年，缓刑3年，并处罚金人民币10000元；潘某犯诈骗罪，判处有期徒刑2年，缓刑3年，并处罚金人民币10000元。案例四山东省烟台市王某等3人伪造证明材料骗保案2023年6月，山东省烟台市龙口市医保部门收到一起涉嫌伪造证明材料骗取医保基金的举报线索，当地医保部门迅速组织力量开展核查。经查，参保人王某于2022年8月在工作期间不慎将手指绞断，属于工伤范畴，但其受雇公司的负责人杨某教唆王某之妻孙某在填写医保报销所需的《意外伤害说明表》时，故意隐瞒工伤事实，谎称王某系“在家中受伤”，从而骗取医保报销费用18070.63元。住院期间，相关押金由杨某缴纳，医保报销费用亦由杨某领取。龙口市医保部门依法向王某和杨某下达《行政处理决定书》，责令其全额退回骗取的医保基金，并将案件线索移送当地公安机关。经公安机关查实，王某、孙某、杨某均不同程度参与了伪造证明材料、骗取医保基金的违法活动。2024年4月，龙口市人民法院判决杨某犯诈骗罪，判处有期徒刑9个月，缓刑1年，并处罚金人民币8000元；王某犯诈骗罪，判处有期徒刑8个月，缓刑1年，并处罚金人民币5000元；孙某犯诈骗罪，判处有期徒刑7个月，缓刑1年，并处罚金人民币5000元。案例五辽宁省本溪市参保人刘某伪造证明材料骗保案2025年7月，辽宁省本溪市医保局桓仁满族自治县分局收到相关部门转来线索，反映参保人刘某涉嫌伪造证明材料骗取医保基金，当地医保部门立即开展调查核实。经查，2024年10月11日，刘某驾驶摩托车与王某驾驶的同向行驶货车发生追尾，事故造成刘某外伤住院。经交通管理部门认定，刘某负该起事故的主要责任，王某负次要责任。在医保报销环节，刘某的家属在填写《保险类别确认书》时，未如实陈述交通事故有第三方责任的事实，将应由第三方承担的部分医疗费用使用医保统筹基金报销，导致医疗保障基金多支出6549.11元。在完成案件调查后，桓仁满族自治县医保分局于2025年8月4日将案件线索移交至桓仁满族自治县公安局，桓仁满族自治县公安局于2025年8月6日立案侦查，于8月8日对嫌疑人刘某采取刑事拘留强制措施。目前，损失的医保基金已全部追回，公安机关正将案件移送检察机关审查起诉。本期5起个人骗保典型案例涵盖倒卖医保药品和伪造证明材料两大类违法行为。从违法形式来看，既有参保人利用特殊病种待遇、低保人员医保待遇超量开药倒卖牟利，也有通过隐瞒第三方责任、伪造受伤原因等虚假证明材料骗取医保报销。从违法后果来看，所有涉案人员均受到刑事处罚，全额退赔骗取的医保基金，教训深刻惨痛。大数据时代，所有违法行为都将留痕，任何触碰医保基金红线的行为，都会付出沉重的法律代价。在此，郑重提醒广大参保群众：切莫因一时贪念，误入骗保歧途。希望大家自觉遵守医保法律法规，珍惜自身医保权益，主动抵制并举报欺诈骗保行为，共同守护好我们每一个人的“健康保障池”，让医保基金真正用在刀刃上、惠及更多需要的患者。

　　经监督检查，广东弘爱药业有限公司等4家药品经营企业的综合评定结论为不符合要求，存在药品质量安全隐患。根据《中华人民共和国药品管理法》第九十九条及《药品检查管理办法（试行）》第六十一条规定，广东省药品监督管理局对广东弘爱药业有限公司等4家药品经营企业采取暂停销售（配送）风险控制措施，现予以公布。序号企业名称药品经营许可证编号综合评定结论风险控制措施1广东弘爱药业有限公司粤AA020000041不符合要求暂停销售2美小季健康药房（广东）有限公司粤BA020000771不符合要求暂停销售（配送）3瓜小多药业（广东）有限公司粤AA020001106不符合要求暂停销售4佛山市正中医药连锁有限公司粤BA757000174不符合要求暂停销售（配送）　　企业应当严格落实主体责任，按照检查处理结果要求暂停销售（配送），排除质量安全隐患后，向广东省药品监督管理局提交整改报告，经复查符合条件后予以解除风险控制措施。　　特此通告。广东省药品监督管理局2025年11月27日

根据《中华人民共和国药品管理法》第九十九条及《药品检查管理办法（试行）》第六十一条、第六十三条规定，广东省药品监督管理局组织对东莞市聚源堂药业有限公司（药品经营许可证号：粤BA769000722）现场检查确认，上述企业已完成缺陷项目整改，现决定对该企业解除暂停销售（配送）药品风险控制措施。　　特此通告。广东省药品监督管理局2025年11月27日

案件名称辽宁万汇祥医药连锁有限公司销售劣药夫西地酸乳膏案处罚决定文书号辽药监(稽三)罚〔2025〕5号被处罚企业名称辽宁万汇祥医药连锁有限公司统一社会信用代码91210381MA0YB06H5P法定代表人张兵兵主要违法事实当事人销售劣药夫西地酸乳膏，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241.56元行政处罚履行方式和期限主动履行；当事人已于2025年11月27日履行完毕。作出处罚的日期2025-11-26

依据国家药品监督管理局《关于进一步做好药品经营监督管理有关规定的公告》（2024年第48号）和安徽省药品监督管理局《关于进一步做好药品经营监督管理有关工作的通告》（2024年第15）有关规定，现将符合我省现代物流要求企业公告如下。序号企业名称许可证编号经营地址仓库地址备注109安徽中为医药有限公司皖AA551000866合肥市包河安徽省滁州市琅琊区安庆路82号高济健康仓储物流华东总部基地项目1#物流仓库主楼1至5楼经济开发区大连路2号万茂云谷2号厂房3层北侧合肥市包河经济开发区大连路2号万茂云谷2号厂房3层南侧110安徽智赋岐黄医药科技有限公司皖AA551000867安徽省合肥市经济技术开发区新港工业园青龙潭路3435号智能科技园（南区）A栋2层（东侧）安徽省合肥市经济技术开发区新港工业园青龙潭路3435号智能科技园（南区）A栋2层（西侧）111安徽章庆誉健康产业发展有限公司皖AA551000869安徽省合肥市肥东县肥东经济开发区镇西路瑞跃智谷科技创新产业园34号楼5层安徽省合肥市肥东县肥东经济开发区镇西路瑞跃智谷科技创新产业园34号楼1-4层112安徽润邦医药有限公司皖AA558a00871安徽省亳州市高新技术产业开发区槐花路917号1号楼一楼安徽省亳州市亳州芜湖现代园区槐花路888号综合仓库一栋2层113安徽医脉达药业有限公司皖AA558a00870安徽省亳州市高新技术产业开发区酒城大道北、汤王大道西安徽亳药千草中药科技有限公司院内5号楼四楼西北侧安徽省亳州市高新技术产业区酒城大道北、汤王大道西安徽亳药千草中药科技有限公司院内5号楼4楼。114安徽省旭昇健康科技有限公司皖AA558a00863安徽省亳州市谯城区经开区研发路西侧、东风沟南侧亳州工业园区A区一号楼二楼1号安徽省亳州市谯城区经开区研发路西侧、东风沟南侧亳州工业园区A区二号楼一楼、二楼115信源药业集团（亳州）制药股份有限公司皖AA558a00856安徽省亳州市谯城区桐花路1373号综合楼5楼/ 安徽省亳州市谯城区桐花路1373号精致小包装车间二、三层。安徽省亳州市谯城区桐花路1373号综合楼5楼/ 安徽省亳州市谯城区桐花路1373号精致小包装车间二、三层。116安徽汇中州医药贸易有限公司皖AA558a00586安徽省亳州市高新技术产业开发区养生大道1558号1号办公楼一楼西侧大厅安徽省亳州市高新技术产业开发区养生大道1558号1号办公楼一楼西侧大厅117安徽瑞拓医药有限公司皖AA558a00854安徽省阜阳市开发区京九街道新阳路198号4号楼101室安徽省阜阳市开发区京九街道新阳路198号4号楼102室118安徽百信医药有限公司皖AA564000296六安市裕安区城南镇工业园区六安市裕安区城南镇工业园区磨子潭南路287号院内3号楼一层119安徽智医慧云科技有限公司皖AA553000851安徽省芜湖市镜湖区范罗山街道观澜路1号滨江商务楼9楼安徽省芜湖市经济技术开发区东区纬三次路55号2#厂房三层（北）120淮南新欣医药有限公司皖AA554000253安徽省淮南市大通区工业新区淮南新欣医药有限公司综合楼一层、二层、四层、五层、六层安徽省淮南市大通区工业新区淮南新欣医药有限公司二号库1-4层121安徽华亿同康医药有限公司皖AA556000864安徽省安庆市迎江区龙狮乡皖江大道北侧迎江世纪城紫峰大厦B座三十五层4-9室安庆迎江经济开发区迎江区应急(医疗等)储备基地院内园区展厅二层(安庆市迎江区环城南路4号安庆迎江普洛斯管理物流园园区展厅二层)122安徽朗坤医药销售有限公司皖AA556000868安徽省安庆市高新区技术产业开发区独秀大道197号3号楼二层东侧安徽省安庆市高新区技术产业开发区独秀大道197号3 号楼2层西侧和4号楼一层二层

各有关单位：　　《北京市进口医疗器械境内代理人监督管理办法（试行）》已于2025年11月28日经市药监局第10次局长办公会审议通过，现印发给你们，请遵照执行。《北京市进口医疗器械代理人管理规定（试行）》同时废止。　　特此通知。　　北京市药品监督管理局　　2025年12月1日　　北京市进口医疗器械境内代理人监督管理办法（试行）　　第一章 总则　　第一条 为加强进口医疗器械监督管理，规范进口医疗器械境内代理人行为，保证进口医疗器械的安全、有效，根据《医疗器械监督管理条例》《医疗器械注册与备案管理办法》《体外诊断试剂注册与备案管理办法》《医疗器械生产监督管理办法》《医疗器械不良事件监测和再评价管理办法》《医疗器械召回管理办法》等法规规章，制定本办法。　　第二条 本办法所称的进口医疗器械境内代理人（以下简称代理人）是指向我国境内出口医疗器械的境外医疗器械注册人、备案人指定协助其履行法定义务的我国境内企业法人。　　第三条 在北京市行政区域内从事进口医疗器械代理活动及其监督管理，应当遵守本办法。　　第四条 代理人从事进口医疗器械代理活动，应当遵守法律、法规、规章等规定，保证代理活动过程信息真实、准确、完整且可追溯。　　第五条 北京市药品监督管理局（以下简称市药监局）负责全市代理人代理活动监督管理工作。　　市药监局各分局负责实施本辖区内代理人代理活动的监督管理工作。　　北京市药品不良反应监测中心负责代理人不良事件监测和进口医疗器械上市后安全性评价相关技术工作。　　第二章 代理人的管理　　第六条 从事进口医疗器械代理活动，应当具备下列条件：　　（一）有与代理产品范围相适应的质量管理机构或者专职质量管理人员，质量管理人员应当具有相关专业学历或者职称，熟悉医疗器械相关法规、规章、标准等要求；　　（二）有与代理产品范围相适应的质量管理制度；　　（三）有与代理活动规模相适应的办公场所；　　（四）国务院药品监督管理部门和市药监局规定的其他条件。　　第七条 从事进口医疗器械代理活动，应当履行下列义务：　　（一）协助境外医疗器械注册人、备案人建立与产品相适应的质量管理体系并保持有效运行；　　（二）协助境外医疗器械注册人、备案人制定上市后研究和风险管控计划并保证有效实施；　　（三）协助境外医疗器械注册人、备案人依法开展不良事件监测和再评价；　　（四）协助境外医疗器械注册人、备案人建立并执行产品追溯和召回制度；　　（五）法律、法规、规章及国务院药品监督管理部门规定的其他义务。　　第八条 代理人与境外医疗器械注册人、备案人应当通过委托授权或者签订协议等方式，明确各自的权利、义务和责任。　　代理人根据境外医疗器械注册人、备案人的委托授权，依法办理医疗器械注册、备案相关事宜；建立与境外医疗器械注册人、备案人之间的信息传递机制并保持有效运行，并留存相关记录；配合药品监督管理部门开展对所代理的进口医疗器械产品质量监管相关工作。　　第九条 代理人与境外医疗器械注册人、备案人委托授权或者签订的协议等发生变化，无法继续履行相应义务的，应当在发生变化之日起5个工作日内书面告知属地市药监局分局，并协助境外医疗器械注册人、备案人在30个工作日内向原注册备案部门申请相应产品变更备案，自完成变更备案之日起，由变更后的代理人履行相应义务。　　第十条 代理人或者境外医疗器械注册人、备案人因违法行为被药品监督管理部门立案调查但尚未结案的，或者收到行政处罚决定但尚未履行，且未完成代理人变更的，原代理人应当继续履行相应义务。　　第十一条 进口医疗器械不符合强制性标准、经注册或者备案的产品技术要求，或者存在其他缺陷的，代理人应当按照医疗器械召回的相关规定，协助境外医疗器械注册人、备案人对境内销售的进口医疗器械实施召回，通知相关经营企业、使用单位或使用者停止经营和使用，采取补救、销毁等措施，记录相关情况，发布相关信息，并将医疗器械召回和处理情况向药品监督管理部门报告。　　第十二条 代理人应当协助境外医疗器械注册人、备案人每年对质量管理体系的运行情况进行自查，并于次年3月31日前向属地市药监局分局提交自查报告。代理人应当确保自查报告内容的真实性、完整性，不得对境外医疗器械注册人、备案人提供的资料进行篡改和删除。　　第十三条 代理人应当协助境外医疗器械注册人、备案人保证进口的医疗器械有中文说明书和标签；说明书和标签应当符合《医疗器械监督管理条例》《医疗器械说明书和标签管理规定》以及相关强制性标准的要求。　　代理人发现进口医疗器械中文说明书和标签的内容与经注册或者备案的相关内容不一致的，应当及时告知并督促境外医疗器械注册人、备案人予以纠正。　　第十四条代理人应当协助境外医疗器械注册人、备案人按照国家实施医疗器械唯一标识的有关要求，开展赋码、数据上传和维护更新，保证信息真实、准确、完整和可追溯。　　第三章 监督管理　　第十五条市药监局负责组织协调本市代理人监督管理工作，制定并组织实施本市代理人年度检查计划，加强代理人监管信息化建设，完善全市代理人信息管理。　　第十六条市药监局各分局应当依据市药监局年度检查计划，结合辖区实际，制定并实施本辖区代理人年度检查计划。检查发现不符合法律、法规、规章、标准等要求或者存在质量安全风险的，应当将检查结果书面告知被检查代理人。需要整改的，应当明确整改内容以及整改期限，并进行跟踪检查。　　必要时，市药监局各分局可以对为代理人活动提供产品或者服务的其他单位和个人开展延伸检查。　　第十七条 对在监督检查中发现存在可能对进口医疗器械质量产生不良影响的问题，或发现进口医疗器械可能存在质量问题的，市药监局各分局可以进行抽查检验。　　第十八条 对进口医疗器械产品存在召回情形的，市药监局各分局及各区市场监督管理部门根据各自职责，按照医疗器械召回的相关规定对召回情况进行监督。　　第十九条 对在监管中发现代理人在代理活动中存在涉嫌违法违规行为的，检查人员应当固定并保留相关证据，及时移交相关部门进行调查处置。　　第二十条市药监局各分局应当至少每季度组织开展本辖区代理人监管安全风险会商，对代理人所代理的进口医疗器械质量安全风险进行分析和评价，必要时及时采取相应的风险控制措施。　　第二十一条 市药监局各分局应当建立本辖区代理人监管信用档案并动态更新，对有不良信用记录的增加监督检查频次，依法加强失信惩戒。　　第二十二条 北京市各级药品监督管理部门应当按照监管职责，建立和完善协同监管机制，对于代理人同时具备医疗器械生产、经营资质的，市药监局各分局可以联合代理人属地的区市场监督管理部门开展检查，实现监管信息共享，做好协同监管。　　第二十三条 在监督检查中发现通过登记的住所或者经营场所无法联系代理人等情形的，市药监局各分局应当及时将相关信息通报给属地的区市场监督管理部门。属地市场监督管理部门查证属实后，根据《企业经营异常名录管理办法》的有关规定，将其列入经营异常名录。　　第二十四条 有下列情形之一的，北京市各级药品监督管理部门可以依职责对代理人法定代表人或者主要负责人进行约谈：　　（一）未协助境外医疗器械注册人、备案人履行法律法规及本办法规定的代理人的义务、责任的；　　（二）对监督检查中发现的问题整改不到位，可能对产品质量产生直接影响的；　　（三）未及时妥善处理进口医疗器械产品质量问题，可能存在质量安全隐患的；　　（四）未按时提交年度自查报告的；　　（五）依法应当进行约谈的其他情形。　　第二十五条 市药监局各分局有下列情形之一的，市药监局应当对相关单位主要负责人进行约谈：　　（一）未及时发现进口医疗器械安全系统性风险的；　　（二）未及时消除辖区内进口医疗器械安全隐患的。　　被约谈的单位应当立即采取措施，对代理人监督管理工作进行整改。　　第四章 附 则　　第二十六条代理人从事医疗器械经营活动的，由各区市场监督管理部门负责监督管理工作。　　第二十七条 医疗器械注册人、备案人注册地为香港、澳门特别行政区和台湾地区的，参照进口医疗器械管理。　　第二十八条 本办法自2026年1月1日起施行，试行期限为3年。原北京市食品药品监督管理局印发的《北京市进口医疗器械代理人管理规定（试行）》（京食药监〔2016〕37号）同时废止。

根据《国家药监局 农业农村部 国家林草局 国家中医药局关于发布特此通告。黑龙江省药品监督管理局2025年12月1日附件                  中药材GAP符合性延伸检查结果被检查主体被检查品种中药材品种基地建设单位基地面积（亩）基地地址经纬度坐标本次检查预计产量检查结果黑龙江珍宝岛药业股份有限公司黄芪注射液，10ml规格（国药准字Z23020782）；20ml规格（国药准字Z23020862）黄芪甘肃九州天润中药产业有限公司2920亩甘肃省定西市岷县申都乡青土村地理位置：点位1:东经104°31′457″，北纬34°40′529″；点位2:东经104°32′719″，北纬34°41′333″；点位3:东经104°32′839″，北纬34°39′273″；点位4:东经104°31′784″，北纬34°38′567″。150020kg符合要求哈尔滨市方圣医药科技有限公司黄芪注射液2ml规格批准文号为（国药准字Z23020781）3120亩地理位置：点位1:东经104°34′194″，北纬34°41′713″；点位2:东经104°32′735″，北纬34°41′218″；点位3:东经104°35′038″，北纬34°41′439″；点位4:东经104°33′261″，北纬34°39′796″。159380kg