Delivery Method:VIA Electronic MailProduct:DrugsRecipient:Arta Shaun NoorianChief Executive OfficerEmpower Clinic Services, LLC dba Empower Pharma5980 West Sam Houston Parkway North, Suite 300Houston,TX77041-5254United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL # 700962April 2, 2025Dear Mr. Noorian: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 July 16, 2016, and most recently on December 6, 2024. From August 1, 2024, to August 28, 2024, FDA investigators inspected your facility, Empower Pharma located at 5980 West Sam Houston Parkway North, Suite 300, Houston, TX 77041. During the inspection, the investigators 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 investigators 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 August 28, 2024. FDA acknowledges receipt of your facility’s responses, dated September 19, 2024, and January 31, 2025. Additionally, FDA acknowledges your firm’s recall of Pyridoxine HCL Injection Solution, 100mg/mL, lot 609763 on September 5, 2024. 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.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)]).B. Failure to Meet the Conditions of Section 503BDuring the inspection, FDA investigators noted that drug products produced by your facility failed to meet the conditions of section 503B. Your facility’s drug products, such as Pyridoxine HCl (B6) Injection Solution, did not include the following information on the container: 1) information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088 and 2) directions for use, including, as appropriate, dosage and administration.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 ProductsFDA investigators noted that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigators observed:1. You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.2. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.FDA investigators 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 and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).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).3. Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)).4. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).5. Your firm failed to establish 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)).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.3Under 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.4The 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 responses to the Form FDA 483. We acknowledge your firm’s recall of Pyridoxine HCL Injection Solution, 100mg/mL, lot 609763 on September 5, 2024, due to lack of sterility assurance.Some of your corrective actions appear deficient:1. Your firm released a batch of a drug product intended to be sterile even though positive microbial growth was detected during environmental monitoring (EM) within the ISO 5 production area. You did not provide an adequate product impact assessment for Pyridoxine HCL lot 609763 compounded on April 18, 2024, when our investigators identified the observation during the inspection. As noted above, we acknowledge your recall of this lot on September 5, 2024. Your response stated you have revised your EM response program procedure to include the requirement that any recovery of a microorganism within an ISO 5 area during final aseptic filtration and filling shall result in the rejection of the associated batch. However, your revision was limited to only two processing steps for aseptic filling and filtration, although any operation in the ISO 5 area has the potential to be affected. Your responses did not provide an investigation update for the microbial failure in which 1 CFU of Bacillus altitudinis/pumilus/safensis was recovered on a surface contact plate inside the ISO 5 laminar airflow hood (LAFH) during aseptic filling. You identified the likely root cause as man (human) and a contributing factor as method due to sampling error, but your investigation did not include any documented preventive actions regarding proper aseptic technique and proper sampling.2. Our investigators observed 6-inch horizontal gaps below the back wall of the ISO 5 LAFH and the bar holes on the side wall of the ISO 5 E2150 LAFH. Your smoke study from June 26, 2023, was not conducted under dynamic conditions to demonstrate unidirectional airflow to include the impact of the gaps and bar holes on your aseptic process in your ISO 5 LAFHs, and to show that airflow could exit through the gaps in the back wall, which could prevent airflow from the ISO 7 cleanroom from entering the ISO 5 LAFH. We acknowledge that you executed an addendum to the original protocol and provided a summary table within document number B-REP-QAL-0168. However, your response did not include an executed protocol per B-PROT-QAL-0069 with documentation completed nor a video with your visual airflow study for review. Your response also lacked an assessment on product impact on lots within expiry made since the smoke study was performed to mitigate any potential concerns until your addendum was completed.3. Your firm exceeded your action level of non-viable particles in the ISO 5 hood during the production of Ascorbic Acid Preserved 500 mg/mL Injection 30 mL lot(b)(4)filled on June 17, 2024. The(b)(4)system(b)(4)counter recorded a total plate count (TPC) that exceeded the action level for particles greater than or equal to(b)(4)microns, according to your internal specification. Your investigation stated the likely contributing factor to the failure was the machine or operator. Your investigation concluded no known product impact, and you released the full batch of Ascorbic Acid Preserved 500 mg/mL Injection 30 mL lot(b)(4). Your investigation stated the operator was properly gowned and maintained proper aseptic practices, but it did not provide an adequate rationale for releasing the whole batch. Your investigation also did not adequately assess the impact of the failure to the ISO 5 environment, for example investigating other operations that had occurred in the ISO 5 area. Any excursion that exceeds an established action level could potentially affect product quality. This is a repeat violation that was discussed during the May 4, 2023, regulatory meeting regarding your failure to establish and follow appropriate written procedures to prevent microbiological contamination.4. Your firm’s investigation of EM out of specification (OOS) results during aseptic batch processing was inadequate. The investigators noted that a fungus,Rhodotorula bacarum, was identified on fingertip samples from an operator during the filling operations on May 4, 2023, of Lipo-B/Methionine/Choline Chloride/Cyanocobalamin 25/50/1 mg/mL, lot(b)(4). Your firm investigated this issue under non-conformance (NC)-000518, but did not determine a definitive root cause. The most probable cause was identified as inadequate gowning or aseptic technique by the operator. Consequently, the operator was disqualified from aseptic production and the batch was rejected. However, the investigation was inadequate as it lacked an assessment on any batches the operator produced before the EM results were available. Also, your investigation stated this employee was working as your(b)(4)equipment lead operator, “which increases the risk of a potential impact to the final product.” Your investigation did not include an assessment of potential other batches involving this operator that utilized the(b)(4)equipment before the EM results were available.In addition, your firm opened approximately fourteen non-conformances (NCs) to investigate EM excursions between August 16 through September 14, 2023. According to your investigation report NC-000673, there were approximately thirty-two NCs for EM excursions reported between August 24 through September 14, 2023. Your investigation report stated the presence of a significant number of EM excursions spanning this period “raises concerns regarding the overall state of control within the 503B aseptic processing suites.”During a review of the combined NC investigation for these EM excursions, your firm failed to extend the investigation to other batches produced. For example, your firm did not include injectable drug product Glutathione 200mg/mL, lot(b)(4); however this lot was manufactured on August 16, 2023. In addition,Pseudomonas luteolawas identified in a routine EM sample collected from the gowning room on August 16, 2023, the same day this lot was aseptically filled. Your response did not include an investigation regarding lot(b)(4). You stated you have revised your Environmental Monitoring Excursion Response Program procedure to extend investigations to other products and lots that may be impacted by the EM excursion. However, it does not appear that your firm is taking a holistic approach to this topic by only making updates to the EM response program procedure. We acknowledge your investigation into these EM excursions stated that most of the referenced batches will be rejected, however we remain concerned with your investigations not always extending to other batches and processes that may be affected. This has been a reoccurring concern from the last inspection and this violation was discussed with you during the May 4, 2023, regulatory meeting.5. Our investigators observed discolored stains and scratches inside both of your ISO 5 LAFHs on August 12, 2024. Your response stated, “the insufficient maintenance of these areas at the time of inspection represented a deviation from established procedures and enhancements to Empower’s program for preventive maintenance of the classified area.” We acknowledge the pictures you provided showing maintenance was performed on the ISO 5 LAFHs based on the cleaning chemical that was used. However, the scratches appear to be embedded in the stainless equipment and may not be removed by cleaning alone. There is a lack of assurance that your newly created checklist forms have adequate details to prevent reoccurrence because they do not include details defining what is considered clean. Your response also stated you performed retraining on preventive maintenance inspections perB-SOP-FACE-0020E2019-CR Preventive Maintenance. However, that procedure was not provided in your response and there was no assessment provided to mitigate any product impact concerns with other released drug products intended to be sterile that were made in the affected ISO 5 LAFH. This is a repeat observation from your August 5, 2022, inspection regarding discoloration on equipment in the ISO 5 area.6. Cleaning validation (CV) for multiple product contact equipment used in compounding implantable Testosterone and Estradiol pellets has not been completed although it appears that your firm continues to produce these products. You state you have already initiated the process of performing CV on the affected equipment prior to the inspection, but that(b)(4). Your response did not provide any type of risk assessment for this gap nor state if your firm has any plans to stop making the product until CV has been performed. You also did not provide any assurance that this gap in CV does not exist for other product contact equipment involving your other numerous products.We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation. For example, your aseptic operators working in both ISO 5 LAFHs equipment ID E2150 and 2151 were observed, via video, on July 31, 2024, sanitizing their gloves prior to performing personnel monitoring (PM). Your aseptic operators failed to immediately perform (PM) after concluding aseptic filling of sterile drug product Lipo-B/Methionine/Choline Chloride/Cyanocobalamin 25/50/1 mg/mL Injection Solution lot(b)(4), as required by your procedure. This practice was also observed concluding aseptic filling of sterile drug products Testosterone Cypionate 200mg/mL lot(b)(4)and Glutathione Preservative Free 200 mg/mL Lot(b)(4), via video, on July 31, 2024. The PM of the aseptic operator who performed aseptic filling in ISO 5 hood equipment ID E2150 was performed by a supervisor.Additionally, this aseptic operator failed to employ proper fingertip plating technique after conducting aseptic filling and was observed(b)(4)media plate, rather than(b)(4)to capture the gloved hands utilized during aseptic production. Your procedure B-SOP-QC-0009, Performing Personnel Monitoring, Revision 001, Effective date: 2- Jan-2024, Section 6.4.1.5 states, “(b)(4).” This practice was also observed concluding aseptic filling of your sterile drug product Testosterone 200mg/mL lot(b)(4)on August 6, 2024. Your response does not address the root cause as to why employees are not following procedures nor the impact of this practice on lots distributed since it is unknown how long this practice has been performed. You stated you will send documentation of periodic monitoring assessments of employees’ aseptic technique in your subsequent 2024-Q4 response by providing copies of executed B-FRM-QC-0013 Environmental Monitoring Sampling Assessment forms as evidence of compliance. However, we have not received your supporting documentation to review. Your 2024-Q4 response dated January 31, 2025, stated you completed twenty-six assessment forms, but you will not provide them until(b)(4). This observation affects multiple lots of drug products intended to be sterile. This is a repeat violation that was discussed with you during the May 4, 2023, regulatory meeting regarding failure by your firm to establish an adequate system for monitoring environmental conditions in aseptic processing areas.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. [See21 CFR 210.1(b), 21 CFR 200.10(b).]Regarding issues related to the conditions of section 503B of the FDCA, we are unable to fully evaluate your corrective actions due to lack of adequate supporting documentation. Specifically, you state that your firm will “transition to standard minimum orderable quantities (“MOQs”) which will allow for standard packaging configuration…This would allow for issuance and reconciliation of standard secondary packaging labels prior to the close out of the associated batch record and subsequent release of the product.” However, you state that “(b)(4).”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.Repeat Violations at FacilityAt a regulatory meeting held on May 4, 2023, FDA discussed similar CGMP violations. You proposed specific remediation for these violations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.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 (# 700962). 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.3The 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.4Your 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).

序号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监武械处罚〔2025〕3号武汉镭健科技有限责任公司周琴914201007963462177生产、经营不符合标准医疗器械当事人生产、经营不合格二氧化碳激光治疗机（编号：MC30240026）行为，违反了《医疗器械监督管理条例》第三十五条第一款的规定。1.没收不合格二氧化碳激光治疗机1台（编号：MC30240026）。2.给予罚款。《医疗器械监督管理条例》第八十六条第（一）项的规定主动履行，已履行完毕湖北省药品监督管理局2025年04月11日

在2024年国家化妆品抽样检验工作中，经山东省食品药品检验研究院等单位检验，产品标签标示名称为北芙美白沐浴露等30批次化妆品不符合规定（见附件）。根据《化妆品监督管理条例》《化妆品生产经营监督管理办法》《化妆品抽样检验管理办法》，国家药品监督管理局要求天津、上海、江苏、浙江、山东、广东、广西等省（区、市）药品监督管理部门对上述不符合规定化妆品涉及的注册人、备案人、受托生产企业等依法立案调查，责令相关企业立即依法采取风险控制措施并开展自查整改。各省（区、市）药品监督管理部门要责令相关化妆品经营者立即停止经营上述化妆品，并依法调查其进货查验记录等情况，对违法产品进行追根溯源，发现违法行为的，依法严肃查处；涉嫌犯罪的，依法移送公安机关。特此通告。附件：30批次不符合规定化妆品信息

行政处罚案件信息摘要行政处罚决定书文号湘药监药罚〔2024〕93号当事人湖南省弘华中药饮片有限公司组织机构代码91430521580945296W法定代表人周平华违法类型生产、销售劣药前胡案行政处罚内容给予你公司如下行政处罚：1.没收召回前胡（批号：230801）2Kg；2.没收前胡（批号：230801）违法所得6864.45元，处货值金额1倍（药品货值金额不足十万元的，按十万元计算）100000元罚款，罚没款合计106864.45元。作出行政处罚决定的行政机关湖南省药品监督管理局作出行政处罚决定的日期2024年4月11日备注

行政执法案件信息公开表（2025年第11期，总第169期）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名称违法企业组织机构代码证/ 统一社会信用代码法定代表人/负责人姓名主要违法事实行政处罚内容决定机关名称处罚决定日期公示日期备注1渝药监械处罚〔2025〕1号重庆三丰医疗器械有限公司生产不符合注册的产品技术要求的医疗器械案重庆三丰医疗器械有限公司91500113092410073N        蒋汉东  当事人生产的02D231204批和05C240302批真空采血管，经陕西省医疗器械质量检验院检验，不符合标准规定。经广西壮族自治区医疗器械检测中心复检，不符合标准规定。当事人的行为违反了《医疗器械监督管理条例》（2021年修订版）第三十五条第一款的规定。依据《医疗器械监督管理条例》第八十六条第一项和《中华人民共和国行政处罚法》第二十八条第二款的规定，责令当事人改正违法行为，并决定给予行政处罚如下：1.没收违法所得10232元；2.罚款17325元。重庆市药品监督管理局2025.04.172025.04.21

行政相对人名称江苏泰德医药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91321291552518377C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张丽欣法定代表人证件类型护照号法定代表人证件号码5**************0证件类型证件号码行政处罚决定书文号苏药监泰检处字〔2025〕01号违法行为类型未按经注册的产品技术要求组织生产医疗器械违法事实当事人于2023年11月13日生产的鼻可乐®鼻腔清洗器（生产批号：12311512，规格型号：240ML/3.5G*5袋洗鼻剂）与产品技术要求中的产品型号不一致处罚依据《医疗器械监督管理条例》第八十六条第（二）项、《中华人民共和国行政处罚法》第五条和第二十八条处罚类别罚款;没收违法所得处罚内容没收违法所得14784元，罚款20000元，罚没款合计34784元。罚款金额（万元）2.000000没收违法所得没收非法财物的金额（万元）1.478400暂扣或吊销证照名称及编号处罚决定日期2025/04/21处罚有效期2025/10/21公示截止期2026/04/21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

为加强药品质量监管，保障公众用药安全，依据年度抽检工作计划，省药监局组织对药品生产、经营、使用单位进行了药品质量抽查检验，现将抽检发现的不符合规定的药品情况通告如下：一、经核查确认，标示6家生产（配制）单位的6个品种共6批次药品，经抽检不符合标准规定。二、相关药品监管部门对不符合规定产品已采取查封、扣押、暂停销售、产品召回等控制措施，并依据相关法律法规对有关生产企业（配制单位）、被抽样单位依法严肃查处，查处情况可查询山东省药品监督管理局或相关市市场监督管理局网站。三、对不符合规定产品及相应生产经营企业、单位，相关药品监管部门要加强监管，督促其查明问题原因，制定落实整改措施，切实消除风险隐患。特此通告。附件1：2025年第2期药品质量通告不符合规定品种名单.xls附件2：不符合规定项目小知识.doc山东省药品监督管理局2025年4月16日(公开属性：主动公开)山东省药品监督管理局2025年第2期药品质量通告不符合规定品种名单序号药品名称标示生产企业药品规格生产批号检品来源检验依据检验结果不符合规定项目检验机构备注1炙甘草河北胡氏宇博药业有限公司中药饮片C366240101乐陵市云红街道办事处社区卫生服务中心《中国药典》2020年版一部不符合规定含量测定济宁市食品药品检验检测研究院2茜草河北康典药业有限公司中药饮片20231101威海市文登区小观镇卫生院《中国药典》2020年版一部不符合规定性状、水分、总灰分威海市食品药品检验检测研究院3化瘀消痔丸平邑县中医医院54g/瓶20240702平邑县中医医院《山东省医疗机构制剂规范》第一版第一册不符合规定微生物限度-需氧菌总数临沂市食品药品检验检测中心4麸炒枳实山东键心堂中药饮片有限公司中药饮片231001山东键心堂中药饮片有限公司《中国药典》2020年版一部不符合规定含量测定德州市食品药品检验检测中心5酸枣仁河北智嘉药业有限公司中药饮片230501济宁任城阜桥街道（至善）社区卫生服务中心《中国药典》2020年版一部不符合规定性状德州市食品药品检验检测中心6环磷腺苷注射液青岛金峰制药有限公司2ml：20mg240515青岛金峰制药有限公司国家药品标准YBH20692005-2014Z不符合规定可见异物烟台市食品药品检验检测中心附件2不符合规定项目小知识一、性状是指药品的物理特征或外观形状，记载药品的外观、臭、味、溶解度以及物理常数等，在一定程度上反映药品的质量特性。二、总灰分主要控制中药饮片中的杂质。三、水分是指药品中的含水量。水分偏高通常与工艺、包装不当以及储运环境等因素有关。水分偏高会引起药品稳定性下降，导致药品水解等。四、可见异物系指存在于注射剂、眼用液体制剂中，在规定的目视条件下能够观察到的不溶性物质，其粒径或长度通常大于50微米。五、含量测定系指用规定的试验方法测定原料及制剂中有效成分的含量，一般可采用化学、仪器或生物测定方法。含量测定与药物的疗效相关。六、微生物限度系对非直接进入人体内环境的药物制剂的微生物控制要求，分为计数检查和控制菌检查两部分。相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称扬州市吉康医疗器械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913210027222142465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蔡天鹏法定代表人证件类型身份证法定代表人证件号码3****************7证件类型证件号码行政处罚决定书文号苏药监扬处字〔2025〕5号违法行为类型生产不符合强制性标准及经注册的产品技术要求的一次性使用吸痰管的行为，违反了《医疗器械监督管理条例》第三十五条第一款规定。违法事实扬州市吉康医疗器械有限公司，生产不符合强制性标准及经注册的产品技术要求的一次性使用吸痰管的行为，违反了《医疗器械监督管理条例》第三十五条第一款规定，依据《中华人民共和国行政处罚法》第二十八条、《医疗器械监督管理条例》第八十六条第一项规定，应予处罚。处罚依据依据《中华人民共和国行政处罚法》第二十八条、《医疗器械监督管理条例》第八十六条第一项规定。处罚类别罚款;没收违法所得、没收非法财物处罚内容没收违法所得柒佰伍拾元整；处以罚款叁万伍仟元整。罚款金额（万元）3.5没收违法所得没收非法财物的金额（万元）0.075暂扣或吊销证照名称及编号处罚决定日期2025/04/16处罚有效期2025/10/16公示截止期2028/04/16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。罚款金额已确认。

行政相对人名称江苏华东医疗器械实业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91321000731168333G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刘银法定代表人证件类型身份证法定代表人证件号码3****************7证件类型证件号码行政处罚决定书文号苏药监扬处字〔2025〕4号违法行为类型重新启用不符合净化要求的闲置车间生产医疗器械未进行报告的行为，违反了《医疗器械监督管理条例》第三十六条、《医疗器械生产监督管理办法》第十五条第二款规定。违法事实江苏华东医疗器械实业有限公司，重新启用不符合净化要求的闲置车间生产医疗器械未进行报告的行为，违反了《医疗器械监督管理条例》第三十六条、《医疗器械生产监督管理办法》第十五条第二款规定，依据《医疗器械监督管理条例》第八十八条第一项、《医疗器械生产监督管理办法》第七十七条规定，应予处罚。处罚依据依据《医疗器械监督管理条例》第八十八条第一项、《医疗器械生产监督管理办法》第七十七条规定。处罚类别罚款处罚内容处以罚款叁万柒仟元整。罚款金额（万元）3.7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处罚决定日期2025/04/16处罚有效期2025/10/16公示截止期2025/07/16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。罚款金额已确认。

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