国家药监局指导各级药品监督管理部门加强医疗器械网络销售监管，依托国家医疗器械网络销售监测平台，加强医疗器械网络销售监测和违法违规线索处置，严厉打击违法违规行为。各级药品监管部门积极行动，查处了一批违法违规案件，切实维护人民群众身体健康和用械安全。现通报4起医疗器械网络销售违法违规案件信息。一、江阴市天宇医疗器械有限公司在淘宝网销售医疗器械,未按照要求展示医疗器械注册证且未按要求整改2024年11月5日，江阴市市场监督管理局根据网络监测线索，对江阴市天宇医疗器械有限公司进行现场检查。经查，当事人在淘宝网销售电子血压计、医用防护口罩等医疗器械，未展示医疗器械注册证信息，被责令改正、给予警告后未按要求改正。上述行为违反了《医疗器械网络销售监督管理办法》第十条规定。2025年1月14日，江阴市市场监督管理局依据《医疗器械网络销售监督管理办法》第四十条规定，给予当事人行政处罚。二、义乌圣荷医疗器械有限公司在天猫商城销售标签说明书不符合规定的第一类医疗器械2024年9月20日，永康市市场监督管理局对义乌圣荷医疗器械有限公司进行监督检查。经查，当事人在天猫商城销售第一类医疗器械医用退热凝胶，该产品标示适用范围:“适用于眼干、眼涩、眼疲劳、眼疼痛、眼部浮肿、充血、酸胀、视力低下、弱视、近视、远视、视网模糊、迎风流泪等不适人群的局部降温”，上述内容与该产品备案的预期用途:“发热患者的局部降温,仅用于体表完整皮肤”不一致。上述行为违反了《医疗器械监督管理条例》第三十九条规定。2025年2月8日，永康市市场监督管理局依据《医疗器械监督管理条例》第八十八条规定，给予当事人行政处罚。三、上海医乐仓医疗器械有限公司在美团平台销售未依法注册的第二类医疗器械2024年9月25日，上海市嘉定区市场监督管理局根据举报线索，对上海医乐仓医疗器械有限公司进行监督检查。经查，当事人在美团平台销售未依法注册的医疗器械硅凝胶，未依照规定执行医疗器械进货查验记录制度。上述行为违反了《医疗器械监督管理条例》第四十五条、第五十五条规定。2025年2月10日，上海市嘉定区市场监督管理局依据《医疗器械监督管理条例》第八十一条、第八十九条规定，给予当事人行政处罚。四、合肥市包河区芮芮造型设计工作室未经许可在美团平台销售第三类医疗器械2024年11月28日，合肥市包河区市场监督管理局对合肥市包河区芮芮造型设计工作室进行现场检查。经查，当事人在美团平台销售第三类医疗器械软性亲水接触镜，未取得医疗器械经营许可证。上述行为违反了《医疗器械监督管理条例》第四十二条规定。2025年2月23日，合肥市包河区市场监督管理局依据《医疗器械监督管理条例》第八十一条规定，给予行政处罚。医疗器械网络销售安全提示：按照《医疗器械监督管理条例》《医疗器械网络销售监督管理办法》等规定，从事医疗器械网络销售活动的，应当在显著位置展示其医疗器械生产经营资质，以及医疗器械注册证或者备案凭证，依法诚信经营，保证医疗器械质量安全。医疗器械网络交易服务第三方平台企业应当持续加强网售合规治理工作，对入网医疗器械经营者经营资质和产品资质加强监测和管理，发现违法违规行为及时制止并报告所在地药品监管部门。药品监管部门将认真贯彻落实“四个最严”要求，加大监管力度，保持高压态势，严惩重处违法违规行为，保障人民群众用械安全。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。

经监督检查，惠州市祥龙医药连锁有限公司等2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《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惠州市祥龙医药连锁有限公司等2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惠州市祥龙医药连锁有限公司粤BA752000704不符合要求暂停销售(配送)2惠州市一芯健康药业有限公司粤BA752000454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4月11日相关推荐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。

福建省药品监督管理局行政处罚信息公开表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社会信用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闽药监厦稽办处罚〔2025〕006号生产不符合经注册产品技术要求的上臂式电子血压计厦门安氏兄弟科技有限公司91350205776019649W 王丰文厦门安氏兄弟科技有限公司生产的上臂式电子血压计（规格型号：AS-35D、批号：P2406022、生产日期：2024-07-03）经检验结果为不符合闽械注准20152070034《上臂式电子血压计》的要求，属不符合经注册产品技术要求的上臂式电子血压计。厦门安氏兄弟科技有限公司生产不符合经注册产品技术要求的上臂式电子血压计的行为，违反了《医疗器械监督管理条例》第三十五条第一款的规定。依据《中华人民共和国行政处罚法》第二十八条第一款、第二款、《医疗器械监督管理条例》第八十六条第一项、《福建省药品监管行政处罚裁量适用细则》第十一条第一款第二项、第四项的规定，本局责令当事人改正上述违法行为，并决定处罚如下：（一）没收违法所得9095.83元（玖仟零玖拾伍圆捌角叁分）；（二）没收召回的4台涉案批次上臂式电子血压计；（三）罚款20000元（贰万元）；上述罚没款合计29095.83元（贰万玖仟零玖拾伍元捌角叁分）。当事人应自接到本行政处罚决定之日起15日内缴纳上述罚没款。根据我局开具的行政处罚缴款通知书，当事人自行选择缴款方式。逾期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条的规定，我局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。 福建省药品监督管理局，2025年4月11日。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。

Delivery Method:VIA UPSReference #:320-25-62Product:DrugsRecipient:Ms. Lina M. KennedyPresident and CEOPMS4PMS, LLC4255 Research PkwyClarence,NY14031-2032United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-62April 7, 2025Dear Ms. Kennedy:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, PMS4PMS, LLC, FEI 3016774658, at 4255 Research Pkwy, Clarence, from November 4 to 8, 2024.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 product is 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, the drug product “Comforté® Menstrual Cramp RELIEF CREAM” is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Additionally, this product is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of a misbranded product into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.We reviewed your November 22, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is 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 investigators observed specific violations including, but not limited to, the following.1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).Your firm failed to adequately determine the appropriate laboratory testing necessary for your OTC drug product. For example, you did not perform testing for identity and strength of the active ingredient prior to release and distribution.We acknowledge that you do not intend to continue manufacturing the “Comforté® Menstrual Cramp RELIEF CREAM” drug product. However, you failed to address the lack of testing of your drug product on the market that is still within expiry.Full release testing, including strength and identity testing of the active ingredient, must be performed before drug product release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that your drug products conform to appropriate specifications before release.2. Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)).You failed to establish and maintain an adequate stability testing program to support the labeled expiry on your distributed drug products. There is no assurance that your drug products will remain acceptable throughout the assigned 5-year expiry period without an ongoing stability program.For products without appropriate stability studies, there is insufficient scientific evidence to support that the drug products will meet established specifications and retain their quality attributes through their assigned expiry.3. 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).You lacked a quality unit (QU) with appropriate oversight for the manufacture of your over-the-counter (OTC) topical analgesic drug product. For example, your QU failed to ensure:Adequate procedures were written and followed describing the roles and responsibilities of the QU, including raw material supplier qualification and incoming component testing (21 CFR 211.22(a) and 211.22(d)).Operators received adequate CGMP training for the production of OTC drug products (21 CFR 211.25(a)).Adequate written procedures for the preparation of master production and control records designed to assure uniformity from batch to batch (21 CFR 211.186(a)).Adequate written procedures to document and investigate any unexplained discrepancy or failure of a batch or any of its components to meet any specifications (21 CFR 211.192).Adequate written procedures to handle drug product complaints (21 CFR 211.198).Your firm’s quality systems are inadequate. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs before you pursue resolution of your firm’s compliance status with FDA. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.Unapproved New Drug and Misbranding Violations“Comforté® Menstrual Cramp RELIEF CREAM” is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B) because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C) because it is intended to affect the structure or any function of the body.Examples from the product’s labeling that provide evidence of the intended uses (as defined by 21 CFR 201.128) of the product as a drug include, but may not be limited to, the following:“Comforté® Menstrual Cramp RELIEF CREAM”“DRUG FACTS…Uses:Temporarily relieves minor pain associated with cramps” [from the product label]“Menstrual Cramp RELIEF CREAM” [from the product label]“…apply and massage Comforté® cream to the lower abdomen from hip to hip and to your lower back if you are experiencing discomfort there too.” [from the product label]“Temporary relief of monthly feminine discomfort” [from the product label]“We believe in the power of plants and their therapeutic properties to offer solutions for menstrual discomforts.” [from the product label]“The natural plant extracts in this cream help to temporarily relieve pain associated with menstrual cramps.” [from the product label]Unapproved New Drug ViolationsBased on the above labeling evidence, “Comforté® Menstrual Cramp RELIEF CREAM” is intended for use as an external analgesic drug product. As described below, this drug product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for this drug product identified above.Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to external analgesic drug products, such as your “Comforté® Menstrual Cramp RELIEF CREAM,” in order to be GRASE and not a new drug, the product must, among other things, conform to the conditions in the applicable OTC monograph(s), here M017: External Analgesic Drug Products for Over-the-Counter Human Use.1However, “Comforté® Menstrual Cramp RELIEF CREAM” does not conform to the conditions specified in M017 for the reasons described below.Specifically, the labeling for “Comforté® Menstrual Cramp RELIEF CREAM” includes indications that are not consistent with the indications for external analgesic drug products. Claims from the product labeling described above related to relief of pain caused by menstrual cramps go beyond merely describing the general intended uses for an external analgesic drug product. Indications related to relief of pain caused by menstrual cramps are not included in M017 or any other final administrative order in accordance with section 505G.Thus, your “Comforté® Menstrual Cramp RELIEF CREAM” product does not comply with the applicable conditions specified in M017 and has not otherwise been found GRASE.2Accordingly, this product is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which this product would be legally marketed without an approved application. Because there is no application in effect for this product, this product is an unapproved new drug.The introduction or delivery for introduction of this unapproved new drug product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsAdditionally, “Comforté® Menstrual Cramp RELIEF CREAM” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because this product is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).Drug Production CeasedWe acknowledge your commitment to cease production of “Comforté® Menstrual Cramp RELIEF CREAM” drugs at this facility. In response to this letter, clarify whether you intend to resume manufacturing any drugs at this facility in the future.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all corrective action and preventive action (CAPA).Cosmetics Manufactured for Distribution in the United StatesIn addition, we note that 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. A cosmetic is deemed adulterated under section 601(c) of the FD&C Act [21 U.S.C. 361(c)] if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health. Some conditions that cause the drug products you manufacture to be adulterated may also cause any cosmetics you manufacture to be adulterated. 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.Further, your facility may be subject to requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Information on MoCRA requirements may be found at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra.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 3016774658 and ATTN: Nancy Scheraga.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of Compliance___________________1M017 reflects the conditions in the relevant final order established and in effect under Section 505G of the FD&C Act; see Order ID OTC000033, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf/ordersearch/order_otc000033.2FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “Comforté® Menstrual Cramp RELIEF CREAM” is GRASE for use under the conditions prescribed, recommended, or suggested in its labeling, nor has FDA determined this drug product to be GRASE pursuant to an order issued under section 505G(b).Center for Drug Evaluation and Research

Delivery Method:Via Electronic Mail - Delivery and Read Receipt RequestedProduct:DrugsRecipient:Robert P. NickellCEONubratori, Inc. dba Nubratori Rx381 Van Ness Avenue, Suite 1507Torrance,CA90501-7220United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERWL #7005131/22/2025You 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 February 24, 2017, and most recently on October 22, 2024. From July 16, 2024, to July 26, 2024, an FDA investigator inspected your facility, Nubratori, Inc. dba Nubratori Rx located at 381 Van Ness Avenue, Suite 1507 Torrance, CA 90501. During the inspection, the investigator noted serious deficiencies in your practices for producing drug products, which put patients at risk.FDA issued a Form FDA 483 to your facility on July 26, 2024. FDA acknowledges receipt of your facility’s responses, dated August 16, 2024, and October 22, 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.An 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.C. Violations of the FDCAAdulterated Drug ProductsFDA 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:1. Lack of adequate personnel sampling. Specifically, glove fingertip sampling was conducted after gloves had been sanitized. Therefore, glove fingertip sampling results are not representative of the aseptic process and may not provide accurate results.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 acceptance criteria for the sampling and testing conducted by the quality control unit that are adequate to assure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. (21 CFR 211.165(d))2. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile. (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 follow written procedures for cleaning and maintenance of equipment. (21 CFR 211.67(b))5. Your firm failed to conduct microbiological testing before use of each lot of a component with potential for objectionable microbiological contamination in light of its intended use. (21 CFR 211.84(d)(6))6. Your firm failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals. (21 CFR 211.84(d)(2))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.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. We acknowledge your response to observation #2 and your statement that there was an unplanned deviation from your normal processes. Based on your response, due to this deviation, compounder(b)(4)was unable to return and assist with the batch, as a result, compounder(b)(4)could only take glove fingertip sampling at that moment. However, glove fingertip sampling should take place prior to sanitizing, as it can prevent recovery of microorganisms that were present during aseptic manipulation. While your firm provided training document detailing the information and training session provided to employees, not enough information was provided explaining what future deviations and ISO 5 manipulations would be taken into account before personnel monitoring is performed.2. In your response to observation #4, you provided updated standard operating procedures (SOP) 3.84Visual Inspection of Sterile Products and Visual Inspection Personnel Qualification, to describe how you will document the complete results of the Quality Control check, however, you did not provide batch records showing how these forms would be implemented and utilized. In addition, no training documentation was provided to show visual inspectors were trained on updated procedures. The updated SOPs provided instructions for a selection of appropriate(b)(4)for inspection of amber vials and established a minimum time for the inspection of each vial against(b)(4). In your response, you state a minimum of(b)(4)would be used, however, your SOP 3.84 states that amber containers “shall use a light of at least(b)(4).” Your response lacked supporting documentation, such as batch records to ensure appropriate(b)(4)will be used during visual inspection. Additionally, no training records were provided to show visual inspectors are trained on updated procedures, nor was it explained how your firm would implement and verify proper length of visual inspection time against(b)(4).In your response, you state, “Defect kit will be updated prior to release of the next production batch for each product. Visual inspectors will be fully trained on each product prior to release of next sterile production batch.” However, you have not provided additional information regarding your updated defect kits and documentation of training performed by your visual inspectors prior to the release of your next sterile production batch. Additionally, your SOP makes note of your Acceptance Quality Limit (AQL), with action and alert limits noted for critical, major, and minor defects. It is unclear how you will utilize this practice going forward, as you did not provide supporting documentation of your firm’s use of AQL, as well as training records.Lastly, updated SOP 3.85 does not provide details on how new defects will be added to your defect kit. SOP 3.85 states “5.1.6. If defects are identified for a distribution batch that is not representative of the current Inspection Qualification Test Kit then the new defected will be added to the library of visual defect form and in the kit.” You did not provide an example of the library of visual defect form. It is unclear if you have a separate and distinct “Inspection Qualification Test Kit” and “Library of Visual Defects.” There was also no training documentation provided to show visual inspectors were trained on updated procedures.3. Your response to observation #1A included updated SOP 3.83Placing and Releasing(b)(4)from Quarantineand any current lots of(b)(4)were quarantined and sent out for growth promotion testing. However, you did not provide results of your growth promotion testing. Growth promotion testing should be performed on all lots of prepared media.4. Your response to observation #3 included training documentation showing operators had been trained on updated SOP 4.11Cleaning Procedure for Cleanroom Before and After Compounding. However, the updated SOP was not provided for evaluation.5. Your response to observation #5 states you sent out current Active Pharmaceutical Ingredient (API) for microbial and endotoxin testing. You also provided an updated procedure, SOP 3.58Placing and Releasing API from Quarantinefor review. However, you did not provide supporting documentation indicating your new limits for endotoxin and microbial counts in the updated SOP, nor did you provide rational as to how these limits were established. Additionally, you did not provide training information and documentation supporting your employees have been properly trained on your new process of evaluating incoming material.Some of your corrective actions appear deficient:1. In your response to observation #6, you provided updated SOP 3.57Vendor Setup and Qualification for APIand state(b)(4)additional lots have been sent out for full COA testing. Your updated SOP states API re-qualification will be completed(b)(4). However, your response did not include any additional information on when API re-qualification will occur and what specific testing will be performed. Components that are not approved finished drug products (both APIs and inactive ingredients) must be tested to verify identity and evaluate for conformity with appropriate specifications and, if necessary and depending on the intended use. Your updated SOP did not provide sufficient details explaining how this new process will be implemented. Also, your response failed to mention the other(b)(4)identified APIs and the plans to send those lots out for testing. Additionally, you did not provide training information and documentation supporting your employees have been properly trained on your new process of evaluating incoming material.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. See section 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).]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.Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov. In your response, refer to the Warning Letter Number above (#700513) and include a subject line that clearly identifies the submission as a Response to Warning Letter.Sincerely,/S/F. Gail Bormel, JD, RPhDirectorOffice of Compounding Quality and ComplianceOffice of ComplianceCenter for Drug Evaluation and Researchcc: Gulshakar Khwaja, RPH, MS, PharmD, Chief Operating Officer____________________1See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).

Delivery Method:Via EmailProduct:DrugsRecipient:Andy GarciaNaturista Store LLC10519 Paramount BLVDDowney,CA90241-2404United StatesHello@naturistastore.comSupport@NaturistaRex.comhello@naturistarex.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 26, 2024RE: 701480Dear Andy Garcia:This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://naturistastore.com/ from Dec 2024 to February 2025, and has observed that your website offered the product “ADVANCE KING”1for sale in the United States. In addition, FDA has obtained a sample of your “ADVANCE KING” product. As described below, this product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, your “ADVANCE KING” product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. 352, and introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).FDA confirmed through laboratory analysis that a sample of your “ADVANCE KING” product contains the undeclared active pharmaceutical ingredients dexamethasone, diclofenac, and methocarbamol. Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Abrupt discontinuation can cause withdrawal symptoms. In addition, the undeclared dexamethasone in “ADVANCE KING” may cause serious side effects when combined with other medications.Diclofenac is a non-steroidal anti-inflammatory drug (NSAID). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines.Diclofenac may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.Methocarbamol is a muscle relaxant that can cause sedation, dizziness, and low blood pressure. Methocarbamol can also impair mental and physical abilities to perform certain tasks, such as driving a motor vehicle or operating machinery.Information on the label and/or labeling of your “ADVANCE KING” product demonstrates that this product is marketed as a dietary supplement.2However, under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i), a dietary supplement may not include an article that is approved as a new drug under section 505 of the FD&C Act unless that article was marketed as a dietary supplement or food before its approval as a drug. FDA approved diclofenac, under the trade name Voltaren, as a new drug on July 28, 1988 and dexamethasone, under the trade name Hexadrol, as a new drug on December 21, 1960. Given that diclofenac and dexamethasone were not marketed as dietary supplements or as food before Voltaren and Hexadrol were approved, “ADVANCE KING,” which contains diclofenac and dexamethasone, is excluded from the definition of a dietary supplement under section 201(ff)(3)(B)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i).Moreover, we note regardless of whether your “ADVANCE KING” product is excluded from the definition of a dietary supplement, it is a drug under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for, among other things, use as an arthritis treatment.Unapproved New DrugYour “ADVANCE KING” product is a drug as defined by 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 observed on your website and from the labeling that provide evidence of the intended use of these products as drugs include, but may not be limited to the following:On your product label:“Hierbas medicinales para CALMAR el DOLOR” (English translation: Herbal medicine to relieve pain)o “Ciática” (English translation: Sciatica)o “Ácido Urico” (English translation: Uric Acid)o “Osteoartritis” (English translation: Osteoarthritis)o “Arteriosclerosis” (English translation: Arteriosclerosis)o “Gota” (English translation: Gout)On your product promotional labeling“Advance King es un suplemento totalmente natural para todos, desde atletas competitivos hasta jubilados que disfrutan de sus años dorados. Nuestra fórmula natural, puede ayudar potencialmente a fortalecer tus huesos, reducir el dolor articular, la rigidez articular y el deterioro del cartílago.” (English translation: Advance King is a totally natural supplement for everyone, from competitive athletes to retired people enjoying their golden years. Our natural formula can potentially help to strength your bones, reduce your joint pain, joint rigidity, and cartilage damage.)“Fortalece y recupera la MOVILIDAD y FLEXIBILIDAD de tus articulaciones” (English translation: Strengthen and regain the mobility and flexibility in your joints)Your “ADVANCE KING” product is not generally recognized as safe and effective for its above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, a new drug 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 is no FDA-approved application in effect for your “ADVANCE KING,” product. Introduction or delivery of this product into interstate commerce without an approved application violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded DrugYour “ADVANCE KING” product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a). Under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), a drug is misbranded if its labeling is false or misleading in any particular. Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that, in determining whether an article’s labeling or advertising “is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in light of such representations.” The labeling for your “ADVANCE KING” product does not declare that the product contains dexamethasone, diclofenac, and methocarbamol. As previously mentioned, these undeclared ingredients in your “ADVANCE KING” product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. The failure to disclose these ingredients in the product labeling renders your “ADVANCE KING” product misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).We also documented that your website https://naturistastore.com/ offered for sale “NatuMex Artri Ajo King,”3“NatuMex Artri King,”4“Royal Honey Sachets,”5“CURCUFLEX,”6“UNAVY,”7“Rmary Hyaluronic Acid,”8“FOREVER FOREVER,”9and “Kukamonga Acido Hialuronico,”10to consumers in the United States. Previous FDA lab analyses of products similarly named to those sold on your website revealed these products contained undeclared drug ingredients. While the Agency has not sampled and tested these product variations from your inventory to date, this letter also expresses our serious concern about the safety of these products and emphasize that it is your legal responsibility under federal law to ensure that products you sell do not contain any undeclared or potentially harmful ingredients, and that they are marketed in compliance with applicable laws.ConclusionThis letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and/or injunction.Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov. Please include your firm name and the unique identifier “CMS 701480” in the subject line of the email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs and Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration___________________1FDA issued a warning to consumers not to use your “ADVANCE KING” product (see: https://www.fda.gov/drugs/medication-health-fraud/advance-king-may-be-harmful-due-hidden-drug-ingredients).2“ADVANCE KING” is labeled as dietary supplement on the product packaging.3https://www.fda.gov/drugs/medication-health-fraud/public-notification-artri-ajo-king-contains-hidden-drug-ingredient4https://www.fda.gov/drugs/medication-health-fraud/public-notification-artri-king-contains-hidden-drug-ingredients5https://www.fda.gov/drugs/medication-health-fraud/public-notification-royal-honey-contains-hidden-drug-ingredient6https://www.fda.gov/drugs/medication-health-fraud/public-notification-rmflex-contains-hidden-drug-ingredient7https://www.fda.gov/drugs/medication-health-fraud/umary-contains-hidden-drug-ingredients8https://www.fda.gov/drugs/medication-health-fraud/umary-contains-hidden-drug-ingredients9https://www.fda.gov/drugs/medication-health-fraud/force-forever-may-be-harmful-due-hidden-drug-ingredients10https://www.fda.gov/drugs/medication-health-fraud/acido-hialuronico-contains-hidden-drug-ingredient

福建省药品监督管理局行政处罚信息公开表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社会信用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闽药监厦稽办处罚〔2025〕006号生产不符合经注册产品技术要求的上臂式电子血压计厦门安氏兄弟科技有限公司91350205776019649W 王丰文厦门安氏兄弟科技有限公司生产的上臂式电子血压计（规格型号：AS-35D、批号：P2406022、生产日期：2024-07-03）经检验结果为不符合闽械注准20152070034《上臂式电子血压计》的要求，属不符合经注册产品技术要求的上臂式电子血压计。厦门安氏兄弟科技有限公司生产不符合经注册产品技术要求的上臂式电子血压计的行为，违反了《医疗器械监督管理条例》第三十五条第一款的规定。依据《中华人民共和国行政处罚法》第二十八条第一款、第二款、《医疗器械监督管理条例》第八十六条第一项、《福建省药品监管行政处罚裁量适用细则》第十一条第一款第二项、第四项的规定，本局责令当事人改正上述违法行为，并决定处罚如下：（一）没收违法所得9095.83元（玖仟零玖拾伍圆捌角叁分）；（二）没收召回的4台涉案批次上臂式电子血压计；（三）罚款20000元（贰万元）；上述罚没款合计29095.83元（贰万玖仟零玖拾伍元捌角叁分）。当事人应自接到本行政处罚决定之日起15日内缴纳上述罚没款。根据我局开具的行政处罚缴款通知书，当事人自行选择缴款方式。逾期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条的规定，我局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。 福建省药品监督管理局，2025年4月11日。福建省药品监督管理局行政处罚决定书闽药监厦稽办处罚〔2025〕006号当事人：厦门安氏兄弟科技有限公司 主体资格证照名称：《营业执照》 统一社会信用代码：91350205776019649W 住所:***法定代表人：王丰文身份证号码：*** 根据河南省药品医疗器械检验院《检验报告》（编号：QX202402933），当事人生产的上臂式电子血压计（规格型号：AS-35D、批号：P2406022、生产日期：2024-07-03）检验结论为“被检样品不符合河南省药品监督管理局综合处关于印发2024年河南省医疗器械抽检产品检验方案的通知（豫药监综执法〔2024〕41号）、闽械注准20152070034《上臂式电子血压计》的要求”。该检验报告显示最大袖带压、泄气、量程、分辨率、可重复性、压力传感器准确性等6个检验项目检验结果均为样品不能正常使用。2024年11月26日，本局向当事人直接送达了该检验报告，并于12月9日立案调查。案件办理期间本局对当事人开展了现场检查，询问调查相关人员等工作。经查，当事人于2024年7月2日-7月4日生产了240台上述涉案批次上臂式电子血压计，经检验合格后于7月4日进行产品放行，入库数量为240台。2024年7月4日，当事人将上述240台产品全部销售给新郑市****有限责任公司，销售金额为9250元，货值金额为9250元。2024年11月27日，当事人对涉案批次上臂式电子血压计进行主动召回。12月31日完成召回工作，共召回4台涉案批次产品。完成产品召回后，当事人向新郑市****有限责任公司开具红字发票，扣减召回的4台产品金额154.17元，故涉案批次产品的违法所得为9095.83元。上述事实，主要有以下证据证明：1.河南省药品监督管理局《关于对不合格医疗器械核查处置的函》（豫药监抽检核查函〔2024〕2087号）、河南省药品医疗器械检验院《检验报告》（编号：QX202402933、规格型号：AS-35D）等材料复印件，证明违法线索来源情况；2.当事人《营业执照》《医疗器械生产许可证》、上臂式电子血压计《医疗器械注册证》及《产品技术要求》等材料复印件，证明当事人的资质情况；3.当事人《管理者代表任命书》、王**、苏**、李**等3人居民身份证复印件以及《花名册》《授权委托书》原件，证明当事人相关人员的身份、职务以及授权委托情况；4.当事人涉案批次的上臂式电子血压计《生产计划单》《物料出库单》《生产过程岗位人员记录》《成品检验报告》《产品放行单》《产成品入库单》等材料复印件，证明当事人涉案批次上臂式电子血压计生产检验及放行情况；5.当事人《AS-35D生产工艺流程图》《生产工艺规程-上臂式电子血压计》《样品管理制度》《上臂式电子血压计成品检验规程》《过程检验规程》等材料复印件，证明涉案产品工艺流程、检验规程等情况；6.当事人销售发货单、销售合同、销售发票、退款发票、帐卡及新郑市****有限责任公司《营业执照》《第二类医疗器械经营备案凭证》等复印件，证明当事人涉案批次产品的销售及退款等情况；7.《协助调查函》（闽药监厦稽办〔2025〕001号）及《关于对福建省药品监督管理局厦门药品稽查办公室协助调查函的复函》（豫药械检业〔2025〕7号）复印件，证明协助调查情况；8.当事人《医疗器械召回事件报告表》《召回计划实施情况报告》《产品抽检不合格原因分析以及纠正措施报告》等材料原件，证明当事人采取风险控制措施、产品召回和售后反馈等情况；9.《现场笔录》《实施行政强制措施决定书》《延长行政强制措施期限决定书》《解除行政强制措施期限决定书》，证明现场核查以及行政强制的实施情况；10.当事人管理者代表苏**、质检部负责人李**《询问笔录》，证明调查询问的情况。2025年4月2日，本局向当事人送达了《行政处罚告知书》（闽药监厦稽办罚告〔2025〕008号），告知当事人拟作出行政处罚内容以及事实、理由、依据，并告知其依法享有陈述、申辩的权利。在法定期限内，当事人未向本局提出陈述、申辩要求。本局认为，当事人违反了《医疗器械监督管理条例》第三十五条第一款的规定，构成了生产不符合经注册产品技术要求的上臂式电子血压计的违法行为。涉案批次产品上述6个项目检验结论不合格系检验过程屏幕显示内容为无效信息，样品不能正常使用。经核查，涉案批次产品按照制定的生产工艺流程图、生产工艺规程，实施包括显示测试、综合性能测试以及按键功能检测在内的生产操作，未发现生产过程屏幕显示异常的情况，产品经检验合格后出厂放行。截至目前未收到涉案批次产品出现不能正常使用等质量问题的情况反映，符合《福建省药品监管行政处罚裁量适用细则》第十一条第一款第四项、第十一条第二款第一项、第八项的规定，综合认定违法行为情节轻微，社会危害后果较小，可以从轻或者减轻行政处罚。此外，在调查取证过程中，当事人积极配合调查，如实陈述违法事实，主动提供证据材料，符合《福建省药品监管行政处罚裁量适用细则》第十一条第一款第二项的规定，可以从轻或者减轻行政处罚。鉴于当事人无从重行政处罚或情节严重的情形，结合案件情况综合考量，本局决定按从轻行政处罚等级进行量罚。依据《中华人民共和国行政处罚法》第二十八条第一款、第二款、《医疗器械监督管理条例》第八十六条第一项、《福建省药品监管行政处罚裁量适用细则》第十一条第一款第二项、第四项的规定，现责令当事人改正上述违法行为，并决定处罚如下：（一）没收违法所得9095.83元（玖仟零玖拾伍圆捌角叁分）；（二）没收召回的4台涉案批次上臂式电子血压计；（三）罚款20000元（贰万元）；上述罚没款合计29095.83元（贰万玖仟零玖拾伍元捌角叁分）。当事人应自接到本行政处罚决定之日起15日内缴纳上述罚没款。根据我局开具的行政处罚缴款通知书，当事人自行选择缴款方式。逾期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条的规定，我局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。 当事人如不服本行政处罚决定，可以在收到本行政处罚决定书之日起六十日内向福建省人民政府申请行政复议；也可以在六个月内依法向福州市鼓楼区人民法院提起行政诉讼。申请行政复议或者提起行政诉讼期间，行政处罚不停止执行。 福建省药品监督管理局2025年4月 11 日 (药品监督管理部门将依法向社会公示本行政处罚决定信息)本文书一式 二 份，一份送达，一份归档。

沈阳沈大内窥镜有限公司报告，由于产品说明书与经注册的相关内容不一致，公司决定对生产的电动刨削器（BXQ-1）实施主动召回。召回级别为三级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。

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社会信用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1闽药监榕稽办处罚〔2025〕6号莆田市金贝康电子科技有限公司未按照经注册的产品技术要求组织生产医疗器械臂式电子血压计案莆田市金贝康电子科技有限公司91350303MA3482160F王美文当事人未按照经注册的产品技术要求组织生产医疗器械臂式电子血压计的行为，违反了《医疗器械监督管理条例》（国务院令第739号）第三十五条第一款的规定，属于《医疗器械监督管理条例》（国务院令第739号）第八十六条第二项情形。根据《中华人民共和国行政处罚法》第二十八条第二款、《医疗器械监督管理条例》（国务院令第739号）第八十六条的规定，现责令当事人改正违法行为并处罚如下1、没收违法所得1645元；2、没收不符合经注册的产品技术要求的臂式电子血压计（规格型号为BK-525,产品批号为BK525230210A）3台；3、处40000元罚款。以上罚没款共计41645元。当事人应在接到本行政处罚决定之日起15日内至福建省药品监督管理局福州药品稽查办公室开具行政罚没收据，至各银行网点缴纳并将缴纳凭证送交我局。到期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条第一项的规定，本局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。福建省药品监督管理局福州药品稽查办公室，2025年4月7日。当事人应在接到本行政处罚决定之日起15日内至福建省药品监督管理局福州药品稽查办公室开具行政罚没收据，至各银行网点缴纳并将缴纳凭证送交我局。到期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条福建省药品监督管理局行政处罚决定书闽药监榕稽办处罚〔2025〕6号当事人：莆田市金贝康电子科技有限公司主体资格证照名称：《营业执照》统一社会信用代码（注册号）：91350303MA3482160F住所（住址）：福建省莆田市涵江区江口镇石西村石庭西路879号法定代表人（负责人、经营者）：******身份证（其他有效证件）号码：******联系电话：****** 其他联系方式： 联系地址：******经查，当事人于2023年2月10日生产的标识规格型号为“BK-525”,产品批号为“BK525230210A”的臂式电子血压计属于第二类医疗器械，当事人在生产该批产品过程中，未严格按照“臂式电子血压计”《医疗器械产品技术要求》（闽械注准20212070077）要求组织生产，以致该批产品外部标识、产品外观以及电源供电方式均不符合《医疗器械产品技术要求》（闽械注准20212070077）的相关规定。本局福州药品稽查办公室于2025年3月27日将《行政处罚告知书》（闽药监榕稽罚告〔2025〕2号）送达当事人，并告知企业有陈述申辩的权利。当事人在法定期限内未提起陈述和申辩。本案未发现有从轻或者减轻行政处罚情节，也未发现有从重行政处罚情节，依法予以一般行政处罚。综上，当事人未按照经注册的产品技术要求组织生产医疗器械臂式电子血压计的行为，违反了《医疗器械监督管理条例》（国务院令第739号）第三十五条第一款的规定。属于《医疗器械监督管理条例》（国务院令第739号）第八十六条第二项情形，根据《中华人民共和国行政处罚法》第二十八条第二款、《医疗器械监督管理条例》（国务院令第739号）第八十六条的规定，现责令当事人改正违法行为并处罚如下1、没收违法所得1645元；2、没收不符合经注册的产品技术要求的臂式电子血压计（规格型号为BK-525,产品批号为BK525230210A）3台；3、处40000元罚款。以上罚没款共计41645元。当事人应在接到本行政处罚决定之日起15日内至福建省药品监督管理局福州药品稽查办公室开具行政罚没收据，至各银行网点缴纳并将缴纳凭证送交我局。到期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条第一项的规定，本局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。 如当事人不服本决定，可以在收到本决定书之日起六十日内向福建省人民政府或者国家药品监督管理局申请行政复议；也可以在六个月内依法向鼓楼区人民法院提起行政诉讼。申请行政复议或者提起行政诉讼期间，行政处罚不停止执行。福建省药品监督管理局2025年4月7日本文书一式 三 份， 一 份送达，一份归档， 一份备案 。第一项的规定，本局将每日按罚款数额的百分之三加处罚款，并依法申请人民法院强制执行。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。

序号1企业名称鞍山市新药特大药房连锁有限公司企业类型药品零售连锁总部检查时间2025年3月12日-2025年3月13日所在地市鞍山市检查依据《药品管理法》《药品管理法实施条例》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律、法规、规范性文件。检查事项药品经营检查检查方式常规检查检查内容执行GSP情况存在问题在药品贮存方面存在个别药品未按包装标示温度储存药品的问题。处理措施责令限期整改整改情况已按要求完成整改  序号2企业名称辽宁先臻医药有限公司企业类型药品批发企业检查时间2025年3月19日-2025年3月20日所在地市鞍山市检查依据《药品管理法》《药品经营和使用质量监督管理办法》《药品经营质量管理规范》等法律、法规、规范性文件。检查事项药品经营检查检查方式常规检查检查内容执行GSP情况存在问题在药品收货验收方面存在个别药品验收后未粘贴验收标示的问题；在质量管理体系文件方面存在部分制度修订不及时的问题。处理措施责令限期整改整改情况已按要求完成整改相关推荐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。