报告，由于甘肃省临夏县市场监督管理局抽样检查中，被检样品不符合额温计《产品技术要求》中2.4.1温度显示范围内最大允许误差。等原因， 北京康祝医疗器械有限公司对其生产的额温计（注册或备案号：京械注准20222070243 ）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》。附件：《医疗器械召回事件报告表》

　　巴尔特科贸（北京）有限公司报告，由于该LEO支架产品收到境内投诉，使用时发现支架实际的长度超过了标签标识的长度。经工厂调查发现生产过程中在同一天生产的两个型号产品之间包装时发生混淆，导致LEO+支架的长度与其标签标识不匹配。等原因， 巴尔特科贸（北京）有限公司对其生产的自膨式颅内支架（注册或备案号：国械注进20173130449 ）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》。附件：《医疗器械召回事件报告表》

开栏的话：近年来，内蒙古自治区药监局以优化营商环境为导向，聚焦涉企监管的痛点、难点、堵点，在监管模式、流程等方面持续创新，一系列务实有效的涉企监管新举措既提升了监管质效，也为企业注入了发展信心。为集中展现内蒙古药品监管在涉企监管领域的新成效，今日起，“内蒙古药监”微信公众号开设“涉企监管新举措・赋能纾困助发展”专栏，重点刊发全区药品监管部门在涉企检查方面的新做法、新成效。敬请关注！为强化药品生产检查精准性与实效性，内蒙古自治区药品检查中心通过数据分析、任务整合、重点突破三个路径，推动药品生产检查从“分散低效”向“精准高效”转变，从源头筑牢药品生产检查安全防线，保障群众用药安全有效。以数据分析为“点”夯实靶向检查基础面将数据深度分析作为精准监管的“导航仪”。每次检查前，紧扣企业历史检查、缺陷整改等“单点数据”，延伸分析产品特性差异，区分高风险品种与常规制剂，系统梳理生产工艺稳定性、关键物料管控等潜在关联风险，提前制定“一企一策”检查清单，让检查实现从模糊排查到精准定位的转变，夯实靶向检查基础。以任务整合为“点”构建高效检查协同面推行“加减结合”机制，以任务整合打破壁垒，实现高效协同检查效果。做好检查频次的“减法”，聚焦同一企业时间相近、内容关联的多项检查任务，将换证许可、变更许可、恢复生产等事项整合打包，形成“一次检查、多事项覆盖”的集约检查模式，避免重复检查、分散监管；做优检查深度的“加法”，依托整合后的协同检查场景，系统深挖跨环节、跨事项的关键风险点，既减轻企业迎检负担，又提升单位时间内的整体监管效能，推动检查从“分散单独”向“高效协同”转变。以重点品种为“点”织密全品种安全防护网紧盯风险关键点位，把检查力量集中投放到重点领域。围绕投诉举报集中、生产工艺变更、原料来源变动等高风险品种，以及集采中选、慢性病用药、儿童用药等群众关注度高的敏感品种，扩大检查覆盖范围，做到重点品种生产环节、检验流程、仓储管理全流程核查无遗漏；延伸检查触角，从重点品种向同类品种、关联辅料供应商等延伸，通过“抓重点带全局”的方式，将单个品种的风险防控经验转化为全品种的安全管理标准，真正织密覆盖药品生产、供应、追溯全链条的全品种安全防护网。通过以上三项举措，实现了药品生产检查从“分散低效”向“精准高效”的转变。下一步，内蒙古自治区药品检查中心将持续优化“以点带面”工作模式，不断细化检查举措、提升检查能力，以更科学的检查、更高效的服务，持续守牢药品生产质量安全底线，切实保障群众用药安全有效。

牡丹江大参林天利医药连锁有限公司超出许可的经营方式经营药品的行为，违反了《中华人民共和国药品管理法》第五十一条第一款、《中华人民共和国药品管理法实施条例》第七十七条之规定。依据《中华人民共和国药品管理法》第一百一十五条、《中华人民共和国药品管理法实施条例》第六十八条第一款第一项、《国家药监局药品监督管理行政处罚裁量适用规则》第十一条之规定进行处罚。

行政相对人名称 圣嘉（滨海）生物医药科技有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91320922MA7DXW5G15 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 邓艾平 法定代表人证件类型 身份证 法定代表人证件号码 4****************3 证件类型 证件号码 行政处罚决定书文号 苏药监盐处罚〔2025〕2号 违法行为类型 违反了《中华人民共和国药品管理法》第九十八条第一款的规定 违法事实 违反了《中华人民共和国药品管理法》第九十八条第一款的规定，依据《中华人民共和国药品管理法》第一百一十七条第一款的规定，应予处罚。 处罚依据 《中华人民共和国药品管理法》第一百一十七条第一款、《中华人民共和国行政处罚法》第二十八条第一款、第五十七条第一款 处罚类别 罚款;没收违法所得;没收非法财物 处罚内容 1、没收召回的药品；2、没收违法所得23319元；3、罚款108004.50元。 罚款金额（万元） 10.800450 没收违法所得没收非法财物的金额（万元） 10.800450 暂扣或吊销证照名称及编号 处罚决定日期 2025/10/22 处罚有效期 2026/04/22 公示截止期 2026/10/22 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

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〕012、012-1、012-2、012-3号厦门美好医药有限公司未遵守药品经营质量管理规范案厦门美好医药有限公司、朱*清、蔡*金、林*晶913502007760342750朱*金 经查，厦门美好医药有限公司未遵守药品经营质量管理规范。违法行为发生期间，董事长朱*清具有最终的决策权和领导权，应负主要责任；质量负责人蔡*金未依法履行质量管理职责，对本案负有一定责任；业务部经理林*晶直接负责企业销售事务，对本案负有一定责任。当事人2023年2月6日至2025年4月25日期间从事药品经营活动未遵守药品经营质量管理规范；2024年1月1日至2025年4月25日，当事人从事药品经营活动未遵守药品经营质量管理规范，且属于情节严重的情形，上述违法行为违反了《中华人民共和国药品管理法》第五十三条第一款、第五十七条的规定。依据《药品管理法》第一百二十六条、《药品监督管理行政处罚裁量适用规则》第十一条第二项、第四十一条、《福建省药品监管行政处罚裁量适用细则》第三条、第十一条第一款第二、七、八、十、十一项、第二十八条的规定，责令当事人改正上述违法行为，并决定处罚如下：1.处罚款200000元（贰拾万元整）。2.没收朱*清自2024年1月1日至2025年4月25日自美好医药所获收入73093.54元，并处所获收入百分之二十的罚款14618.71元，两年禁止从事药品生产经营等活动。3.没收蔡*金自2024年1月1日至2025年4月25日自美好医药所获收入58656.68元。4.没收林*晶自2024年1月1日至2025年4月25日自美好医药所获收入71630.68元。当事人应当自接到本行政处罚决定之日起十五日内，缴纳上述罚没款。当事人根据厦门药品稽查办公室开具的《福建省非税收收入缴款通知书》，自行选择缴款方式。到期不缴纳罚款的，依据《中华人民共和国行政处罚法》第七十二条的规定，本办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9月22日。

Delivery Method:VIA UPSReference #:320-25-117Product:DrugsRecipient:Mr. Guo GuorongChairman & General ManagerGuangxi Yulin Pharmaceutical Group Co. Ltd.No. 1 Chengzhan Rd.Yulin ShiGuangxi Zhuangzuzizhiqu,537001ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesUnited StatesWarning Letter320-25-117September 30, 2025Dear Mr. Guorong:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Guangxi Yulin Pharmaceutical Group Co. Ltd., FEI 1000589993, at 1 Chengzhan Road in Yulin, Guangxi, from March 17 to 21, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We acknowledge receipt of your response to our Form FDA 483 and 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(b)(4)over the counter (OTC) drug products. For example, you did not perform testing for identity and strength of the active ingredients prior to drug product release and distribution. This is a repeat observation from the 2016 inspection.In your response, you indicate your intent to conduct active ingredient testing for retain samples of batches that have been distributed to the United States and to develop a risk assessment. However, your response is inadequate because you do not propose a comprehensive corrective action and preventive action plan to ensure that appropriate testing is conducted prior to drug product release. In addition, you do not indicate further actions that your firm will pursue for distributed drug products if test results are found to be outside specification.Full release testing, including strength and identity testing of the active ingredients, must be performed before drug product release and distribution. Without adequate testing, you do not have adequate scientific evidence to ensure that your drug products conform to appropriate specifications before their release.2. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).Your firm failed to demonstrate that your test methods were appropriate to assure that your product conforms to appropriate standards of identity, strength, quality, and purity. For example, your test methods and specifications are based on the Chinese Pharmacopeia (ChP). However, you failed to establish that these test methods and specifications are scientifically sound and appropriate, or that they are equivalent to or better than the current United States Pharmacopeia (USP) compendial methods.In your response, you state that you will compare the differences in testing methods for(b)(4)and(b)(4)between the ChP and the USP, and then conduct validation on the revised methods. However, your response is inadequate because you fail to comprehensively assess the appropriateness of the methods and specifications used during system suitability and for the testing of other components and finished drug products.Test methods must be validated to show that they are suitable for their intended use, and equivalent to or better than applicable USP compendial methods. The reproducibility of your test methods is essential to determine if your drug products meet established specifications.Without appropriate test methods, you do not have scientific evidence to support whether your drug products meet their established specifications through their labeled expiry.3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)).Your firm does not have adequate stability data to demonstrate that the chemical and microbiological properties of your drug products meet established specifications and remain acceptable throughout their labeled shelf life. For example, you have not established an appropriate stability program (e.g., frequency and methods) to assess stability characteristics, to ensure that your drug products meet their appropriate strength and quality attributes through their(b)(4)shelf life.In your response, you propose to perform tests once a year during the stability test period. However, your response is inadequate because you do not provide scientific rationale or a formal written risk assessment to support this yearly frequency.Without appropriate stability studies, you lack adequate scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.4. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).Your laboratory equipment lacked sufficient controls to prevent and detect deletion or manipulation of your laboratory's electronic raw data. For example, your ultraviolet-visible (UV-vis) and infrared (IR) spectroscopy equipment was found to lack audit-trail functionality, and your analysts were able to alter and delete data, files, and folders. This is a repeat observation from your 2016 inspection.In your response, you commit to performing audit-trail reviews for active ingredient assays before batch release. However, your response is inadequate because your commitment does not include the review of other electronic laboratory data associated with component and finished-product testing. Furthermore, you fail to provide review procedures designed to ensure data accuracy and integrity.Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance documentData Integrity and Compliance With Drug CGMPfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.Repeat Observations at FacilityIn a previous inspection, dated September 29, 2016, FDA cited similar CGMP observations. You proposed specific remediation for these observations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.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. 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 corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. See FDA’s guidance for industry,Quality Systems Approach to Pharmaceutical CGMP Regulations, at https://www.fda.gov/media/71023/download.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.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.FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on September 26, 2025.Correct any violations promptly. 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 any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Guangxi Yulin Pharmaceutical Group Co. Ltd., in Yulin, Guangxi, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working 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 1000589993 and ATTN: Samantha Bradley.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:Via EmailProduct:Drugs、Over-the-Counter DrugsRecipient:Anthony MoloneyGroup CEOMelcare Biomedical Pty Ltd451 West Mount Cotton RdMount CottonQLD4165Australiaanthonym@melcare.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTEROctober 9, 2025RE: 717968Dear Mr. Moloney:This letter is to advise you that on September 10, 2025 the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including your website at the internet address melcare.com where your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops drug products are available for purchase in the United States without a prescription. We also reviewed your social media site on YouTube https://www.youtube.com/watch?v=W0nofWh_uGU&t=12s, which is listed on your website.Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops drug products are unapproved new drugs 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), 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under sections 301 (d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.Unapproved New Drug and Misbranded Drug ViolationsOptimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops are “drugs” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are 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 they are intended to affect the structure or any function of the body.Examples of claims from the Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops labeling, including on your website listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:Optimel Manuka+ Forte Eye Gel“DRUG FACTS…USES…▪for the temporary relief of irritation due to dryness of the eye. ▪ for use as a protectant against further irritation or to relive dryness of the eye.” [from the Drug Facts panel on product carton labeling]“Suitable For: ▪Aqueous tear deficiency ▪ eye discomfort ▪ eye lid irritation [from your product website at https://melcare.com/product/optimel-manuka-forte-eye-gel/]“Melcare’s Optimel Manuka+ Forte Eye Gel contains a standardised [sic] medical grade Manuka honey developed fromLeptospermumspp. and is preservative free for moderate to severe dry eye” [from your product website at https://melcare.com/product/optimel-manuka-forte-eye-gel/]“Albietz and Lenton also reported that the application of medical gradeLeptospermumspp honey (Manuka) was associated with signficant [sic] clinical improvements in dry eye and meibomian gland dysfunction” [from your product website at https://melcare.com/product/optimel-manuka-forte-eye-gel/]“Indications…Optimel Manuka+ Forte Eye Gel containing 98% honey with increased viscosity is preservative free, and is also available for more difficult conditions from your eye care specialist.” [from your product website at https://melcare.com/product/optimel-dry-eye-drops/]Optimel Manuka+ Dry Eye Drops“DRUG FACTS…USES… ▪for the temporary relief of irritation due to the dryness of the eye. ▪ for use as a protectant against further irritation or to relieve dryness of the eye.” [from the Drug Facts panel on product carton labeling]“Suitable For: ▪Chronic dry eye ▪ Eye discomfort ▪ Sore, irritated eyes and eyelids” [from your product website at https://melcare.com/product/optimel-dry-eye-drops/]“About the Product…Albietz and Lenton also reported that the application of medical gradeLeptospermumspp honey (Manuka) was associated with signficant [sic] clinical improvements in dry eye and meibomian gland dysfunction.” [from your product website at https://melcare.com/product/optimel-dry-eye-drops/]Multiple products“At Melcare, we are experts in the therapeutic use of honey in products to help relieve some of the symptoms associated with chronic disease. Honeys from Australian and New ZealandLeptospermumspp, commonly called Manuka, a small native tree is favoured because of its well-studied composition and antibacterial activity.” [from your product website at https://melcare.com/about-us/]YouTube video posted on your website created on June 18, 2020 that includes statements by Melcare’s President, Anthony Maloney, emphasizes the use of honey and it’s benefits in drug products. For example, Mr. Maloney states in the video, “We developed a range of products that use and leverage off the therapeutic efficacy of honey that is in wound care, eye care, skin care, and throat care.” [from your YouTube video on your product website at https://www.youtube.com/watch?v=W0nofWh_uGU&t=12s]Unapproved New Drug ViolationsBased on the above labeling evidence, your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops are intended for use as ophthalmic demulcent (lubricant) drug products. As described below, these drug products are unapproved new drugs 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 application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for any of the product identified above.Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”— may be legally marketed if they meet applicable requirements. With respect to nonprescription ophthalmic drug products, such as your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops, in order to be GRASE and not new drugs, these products must, among other things, conform to the conditions in the applicable OTC monograph, here OTC monograph M018: Ophthalmic Drug Products for Over-the-Counter Human Use (hereinafter M018).1However, your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops drug products do not conform to the conditions specified in M018 for the reasons described below, and thus cannot be legally marketed under section 505G.Specifically, your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops products are formulated with honey (fromLeptospermumspp.). Although you identify honey as an inactive ingredient on the product label, statements on your website show that honey is presented as an active ingredient, because it is intended to furnish pharmacological activity for the treatment of a disease or condition.2However, honey is not an active ingredient permitted for OTC monograph ophthalmic demulcent drug products under M018.12. Examples of you labeling statements presenting honey as an active ingredient include, “Optimel Manuka+ Forte Eye Gel contains a standardised medical grade Manuka honey developed fromLeptospermumspp. and is preservative free for moderate to severe dry eye,” “The application of medical gradeLeptospermumspp honey (Manuka) was associated with significant clinical improvements in dry eye and meibomian gland dysfunction,” and “We are experts in the therapeutic use of honey in products to help relieve some of the symptoms associated with chronic disease.” Additionally, a YouTube video created on June 18, 2020 and posted on your website includes statements by Melcare’s President, Anthony Maloney, describing the medical benefits of honey. For example, Mr. Maloney states, “We developed a range of products that use and leverage off the therapeutic efficacy of honey that is in wound care, eye care, skin care, and throat care.” Thus, honey is used in your product as an active ingredient and, because it is not an active ingredient permitted under M018.12, your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops products do not conform with the conditions for lawful marketing of an OTC ophthalmic demulcent or vasoconstrictor drug product as set forth in M018.Therefore, your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops drug products do not comply with the applicable conditions specified in M018. In addition, these products have not otherwise been found GRASE.3Accordingly, these products are new drugs 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 these products would be legally marketed without an approved application. Because there are no approved applications in effect for these products, these products are unapproved new drugs.The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).Misbranded Drug ViolationsAdditionally, your Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are 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).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 injunction.Please notify FDA in writing, within 15 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 15 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 717968 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 AdministrationCc:(b)(4)__________________1M018 reflects the conditions as set forth in the relevant final orders established and in effect under section 505G; see Order OTC000023, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf.2See21 CFR 201.66(b)(2), which defines an active ingredient as “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.”3FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that Optimel Manuka+ Forte Eye Gel and Optimel Manuka+ Dry Eye Drops products are 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).

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-25-112Product:Drugs、Over-the-Counter DrugsRecipient:Ms. Teresa L. BandrowskyOwnerBRS Analytical Services, LLC11697 Lakeside Crossing CourtSt. Louis,MO63146-8606United States(b)(6), (b)(7)(C)Issuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-112September 17, 2025Dear Ms. Bandrowsky:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility and contract testing laboratory, BRS Analytical Services, LLC, FEI 3023604380, at 11697 Lakeside Crossing Court, St. Louis, from March 10 to 26, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your April 14, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas. Your firm also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.42(c)(10) and 211.63).Cleanroom DesignYour ISO 5 area used for aseptic compounding and filling sterile over-the-counter (OTC)(b)(4)drug products was fundamentally unsuitable for its intended use. For example, your ISO 5 area had gaps in the wall intended to separate it from the immediately surrounding unclassified warehouse, including large gaps between most wall sections and the floor. Some of these gaps contained mesh screens that appeared to be dirty. Furthermore, you failed to maintain an adequate differential pressure between the ISO 5 area and the warehouse, and did not continuously monitor that pressure. The lack of both physical and aerodynamic segregation in your aseptic processing facility design posed an unacceptable risk to product sterility.The ISO 5 area is critical because sterile drug products are exposed and are therefore vulnerable to contamination. Your aseptic manufacturing facility, equipment, and process must be designed, and operations must be executed, to minimize contamination hazards to your sterile drug product. The unacceptable design of your operation precluded the ability to maintain asepsis.Environmental MonitoringYou failed to establish an adequate system for monitoring environmental conditions. For example, you did not routinely perform viable air monitoring during production, despite a procedural requirement to do so. In addition, your nonviable particle monitor was placed on top of the enclosed cabinet in which filling occurred instead of inside it, rendering the resulting data non-representative of the environmental conditions near the areas of critical exposure on the aseptic processing line. Finally, you failed to routinely review environmental monitoring data prior to batch release.Vigilant and responsive environmental and personnel monitoring programs provide meaningful information on the state of control of the aseptic processing operation, and enable an early warning system that identifies emerging contamination hazards before sterility is compromised. Operations that include highly(b)(4)intensive aseptic activities warrant a more extensive environmental and personnel monitoring program, including but not limited to an emphasis on increased sampling that monitors ongoing batch production conditions more extensively.Facility Maintenance DeficienciesDuring the inspection, we observed your facility to be in a state of disrepair or unclean in several instances. This includes, but is not limited to, the following deficiencies within your aseptic processing room:• Discoloration and apparent residue on light panels above the aseptic filling equipment during operations.• Chipped paint on a floor scale.• Discoloration on the(b)(4)sterilizer and a table.2. 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)).Poor Aseptic BehaviorWe observed poor practices in ISO 5 areas during your(b)(4)intensive aseptic processing of sterile(b)(4)drug products, including but not limited to:• Operators blocked unidirectional airflow during routine production by placing their gloved hands and hooded, masked heads directly over open sterilized bottles.• The skin surrounding operators’ safety glasses was exposed in the ISO 5 area.• Use of nonsterile face masks.• Use of nonsterile paper towels in the ISO 5 area, including inside the filling cabinet.• Failure to seal a vessel containing sterile drug product. Instead of a securely fitted cap, you used an(b)(4)intended to cover an open port in the sterile(b)(4)holding tank in the ISO 5 area during the filling process, which was typically run for(b)(4)days and did not include additional sterilizing(b)(4). In addition, our investigators observed condensation inside the(b)(4), as well as air gaps that provided an avenue for ingress of(b)(4)air.Inadequate Media Fill ProgramYour media fills failed to accurately simulate commercial operations. You only incubated approximately(b)(4)of units for each media fill, rather than(b)(4)units. In contrast, your protocols required(b)(4)units that passed inspection to be incubated. In addition, each media fill lasted only approximately(b)(4)or less, although your commercial aseptic filling operations typically lasted(b)(4)days.It is essential that(b)(4)media fill units be incubated and examined for evidence of microbial contamination. Also, to accurately simulate contamination risks, the duration of the process simulation for(b)(4)intensive lines normally should be no less than the length of the actual manufacturing process.Inadequate Assurance of Sterilization• The validation of the(b)(4)sterilization process used to sterilize direct product contact parts, including transfer hoses and sterilizing(b)(4), was inadequate. For example, the(b)(4)sterilization validation process did not include the use of biological indicators. Instead,(b)(4)water was placed in jars and tested for sterility. Notably, one of these jars of water tested positive for growth, but you did not conduct an investigation.• Sterilizing(b)(4)were not integrity tested for each batch of drug products manufactured.It is essential that product contact equipment is sterile to be suitable for its intended use. Sterilization cycle validation is established through studies that incorporate rigorous physical and biological measurements. Between uses, sterile equipment must be held under ISO 5 conditions and continuously maintained in a manner that prevents contamination.Inadequate Smoke StudyYour smoke study did not adequately demonstrate unidirectional air flow in the ISO 5 area that was used for the aseptic filling of(b)(4)drug products. For example:• Your smoke study did not evaluate unidirectionality. Instead, you turned off the HEPA-(b)(4)fans, filled the ISO 5 area with smoke, then turned the fans on and verified that the room was cleared of smoke.• You failed to conduct a smoke study with your actual filling equipment present.• Your smoke study was not conducted under dynamic conditions.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)Your quality unit (QU) failed to maintain adequate CGMP oversight and allowed the distribution of sterile(b)(4)drug products manufactured under unacceptable conditions, which included poorly designed facilities, an unsuitable aseptic manufacturing process, and deficient environmental monitoring. You also failed to ensure implementation of an effective qualification and validation program, and perform adequate antimicrobial effectiveness studies for your multi-dose aqueous-based sterile(b)(4)drug products.In addition, you failed to ensure that adequate procedures were followed describing the roles and responsibilities of the QU including, but not limited to, raw material supplier qualification.Significant findings in this letter indicate that your QU was not fully exercising its authority or responsibility. Your firm must provide the QU with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality.Drug RecallOn April 17, 2025, FDA held a teleconference with you recommending that you remove from the U.S. market all batches of(b)(4)drug products currently in distribution. On April 21, 2025, you committed to ceasing the manufacture and distribution of all(b)(4)drug products and agreed to a voluntary recall of all(b)(4)drug products currently in distribution in the U.S. On April 23, 2025, you issued a voluntary recall of all(b)(4)drug products due to CGMP deviations and lack of assurance of sterility. The company announcement was posted to the FDA website: https://www.accessdata.fda.gov/scripts/ires/?Event=96741.Drug Production CeasedWe acknowledge your commitment dated June 24, 2025, to permanently cease production of all drugs at this facility.Notify this office if you intend to resume your drug manufacturing operations at this site or in another location. You are responsible for resolving all deficiencies and systemic flaws to ensure that 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 actions and preventive actions (CAPA).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(b)(4)1of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPA 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.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 3023604380 and ATTN: Russell Riley.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCc:(b)(4)(b)(6), (b)(7)(C)_____________1i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.

今年以来，宁德市柘荣县市场监督管理局严格落实省局药械使用环节“清规”行动部署要求，坚持以服务强根基、以监管筑防线，筑牢药械使用质量安全防线。截至目前，全县已完成82家医疗机构规范化药房（库）建设工作，覆盖率96.5%。一是监管联动聚合力。联合卫健局设立“规范化药房”建设工作专班，出台《柘荣县医疗机构“规范化药房（库）”建设工作实施方案》，共同编写“规范化药房”建设标准指南，详细梳理全县医疗机构底数，采取分级分类管理，确保底子清、标准明、管得好。今年以来，对一级以上医疗机构开展联合检查20余次。二是前置帮扶提质效。在督促各医疗机构开展自查的同时，针对性地进行规范药房前置指导工作。通过实地查看结合座谈交流的方式，重点了解医疗机构当前制度建设与设施设备管理的情况，并对发现的问题进行现场指导，提出整改建议，帮助医疗机构在规范化药房建设初期就明确建设的具体要求和实施路径，累计开展帮扶指导50余次。三是宣传培训共提升。将规范化药房建设纳入医疗机构院长目标年薪制绩效考核，明确建设目标与推进时间节点。举办药械使用环节规范化管理专题培训会，对建设标准指南展开系统讲解，组织开展现场实训，邀请各医疗机构代表前往县医院等规范药房建设示范点进行实地观摩，现场交流分享常见问题与做法经验。截至目前，已开展专题培训3期，参训150余人次。四是交叉检查补短板。建立“交叉检查+回头看”长效监督机制，采用“不定期回头看、异地交叉、随机抽查”的模式，重点核查规范化建设成效，检查药品购进、储存、处方审核、特殊药品管理及历史问题整改情况。已交叉检查医疗机构12家次，发现问题8项，整改率100%，有效巩固“规范化”药房建设成果。