按照《中华人民共和国药品管理法》《中华人民共和国行政许可法》和《药品经营和使用质量监督管理办法》等相关规定，根据企业申请，现注销新乡市辰之鑫医药连锁有限公司的《药品经营许可证》（证书编号：豫BA373000032）。　　特此公告。　　附件：新乡市辰之鑫医药连锁有限公司《药品经营许可证》有关信息表　　2026年1月28日附 件新乡市辰之鑫医药连锁有限公司《药品经营许可证》有关信息表企业名称企业法人（负责人）质量负责人经营方式经营范围注册地址仓库地址证书编号新乡市辰之鑫医药连锁有限公司师延珍(王聪聪)孙红伟零售连锁总部处方药、甲类非处方药、乙类非处方药：中药饮片（含冷藏药品）、中成药（含冷藏药品）、化学药（含冷藏药品）、血液制品（含冷藏药品）、其他生物制品（含冷藏药品）***原阳县阳和社区祖师庙村16号原阳县阳和社区祖师庙村16号豫BA373000032

为深入贯彻落实习近平总书记“四个最严”要求和关于“人民至上、生命至上”重要理念，进一步规范“两品一械”投诉举报处置，加大案件查办力度，强化队伍履职能力，切实守护人民群众生命健康安全，1月26日，省药品监管局开年业务第一会组织召开省、市（州）、县（区）、所四级业务工作视频会。全面总结2025年“两品一械”投诉举报和案件查办两项工作，分析研判形势，安排部署重点工作任务。会议认为，2025年全省各级药品监管部门紧扣年度重点工作部署，着力投诉举报合规处置和案件查办，取得积极成效。投诉举报按时办结率、合规率均达100%；全年查办案件363起，同比增长22%，罚没款579.94万元，移送公安机关案件8起，有效震慑了违法行为。会议指出，“两品一械”安全事关群众生命健康与社会和谐稳定，投诉举报、案件查处是排查问题、防控风险、消除隐患、除恶扬善的关键，更是践行党的根本宗旨、为民办实事解难题的重要举措。每条线索都承载着群众对安全用药的期盼和合法权益的诉求，做好规范处置投诉举报、从严从快查办案件工作意义重大、责任重大。会议要求，一要提高政治站位，深刻认识做好投诉举报和案件查办工作的重要性。以贯彻国家部署、深化平安建设、践行为民宗旨为定位，重视群众诉求，抓实案件查处，做到依法处置、及时办结，消除安全隐患、化解矛盾纠纷，提升群众信任度，保障考核成效，守护群众生命健康与社会和谐稳定。二要聚焦关键环节，着力构建权责清晰、运转高效、奖惩分明的处置工作机制。压实层级责任，严格闭环处置，线索即时响应研判分流，依法立案、规范取证、精准执法，按期反馈；以限期办结率、群众满意率为核心指标，健全考核机制。三要强化作风建设，以高度的责任担当筑牢药品安全防线。坚决纠治形式主义、官僚主义，严禁有案不查、有案不办等行为，以务实作风妥善处置每起投诉举报，筑牢药品安全防线。会后，对新修订《市场监督管理投诉举报处理办法》（国家市场监督管理总局令第121号）进行了解读，并就全国12315平台实操、投诉举报合规处置等工作开展专题培训。

　　沃芬医疗器械商贸（北京）有限公司报告，我们已经确认客户投诉，特定血气测定试剂盒（电极法）（见附录A）在预热阶段出现“未检测到过程控制液”（PCSND）的报错频率可能增加，导致血气测定试剂盒（电极法）被弹出，需重新插入新的血气测定试剂盒（电极法）。iQM2 为实时质量过程控制程序，旨在对整个检测过程进行持续监控。因此，若血气测定试剂盒（电极法）在预热后完成 AutoPAK 验证，仍可继续使用。该问题不会对患者检测结果造成任何潜在安全风险。 预热阶段若出现血气测定试剂盒（电极法）连续弹包，重新更换试剂盒可能延长样本周转时间，进而可能延误患者的对症诊疗。因此，一旦获得检测结果，可能需要重新评估患者管理方案。 尽管多数试剂盒仍能按预期正常工作，但连续弹包会增加检测中断的风险。因此，建议在条件允许的情况下提前做好规划，尽可能减少此类情况造成的影响。 沃芬医疗器械商贸（北京）有限公司对其生产的血气测定试剂盒（电极法）GEM Premier 5000 PAK（注册或备案号：国械注进20192400546 ）主动召回。召回级别为二级。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》

　　百多力（北京）医疗器械有限公司报告，在生产过程中发现，部分批号的西罗莫司洗脱冠状动脉支架输送系统的远端柔性段上的亲水涂层存在不均匀现象，这种亲水性涂层旨在提高输送系统的在冠状动脉输送过程中的滑动性能。 在模拟临床最坏情况的体外模型（模拟了迂曲且钙化的冠状动脉结构）上测试了相关批号产品，发现其亲水涂层可能会出现移动和剥离。在模拟测试的部分案例中，可能导致涂层颗粒脱落，这些颗粒可能会进入患者血液，在细小（直径

2025年度行政许可实施情况制表单位（盖章）：四川省药品监督管理局                                                                                                      制表日期：2026年1月26 日序号统一社会信用代码单位全称行政许可实施数量（件）撤销许可的数量申请数量受理数量许可的数量不予许可的数量111510000MB1808933T四川省药品监督管理局4370643706438088187合计4370643706438088187填表说明：1. “申请数量”的统计范围为统计年度1月1日至12月31日期间许可机关收到当事人许可申请的数量。2. “受理数量”、“许可的数量”、“不予许可的数量”、“撤销许可的数量”的统计范围为统计年度1月1日至12月31日期间许可机关作出受理决定、许可决定、不予许可决定的数量，以及撤销许可决定的数量。3. 准予变更、延续和不予变更、延续的数量，分别计入“许可的数量”、“不予许可的数量”。2025年度行政检查实施情况制表单位（盖章）：四川省药品监督管理局                                                                                                         制表日期：2026年1月26 日序号统一社会信用代码单位全称行政检查总数非现场检查现场检查数双随机检查专项检查综合查一次111510000MB1808933T四川省药品监督管理局1203871116015669合计1203871116015669填表说明：1.行政检查次数的统计范围为统计年度1月1日至12月31日期间开展行政检查的次数。2.检查1个检查对象，有完整、详细的检查记录的，计为开展1次行政检查。3.无特定检查对象的巡查、巡逻，无完整、详细检查记录，为查证违法事实而开展调查的，不计入检查次数。4.专项检查数据为根据国家药品监督管理局部署开展的检查事项。2025年度行政处罚实施情况制表单位（盖章）：四川省药品监督管理局                                                                                                           制表日期：2026年1月26 日2025年度行政强制实施情况制表单位（盖章）：四川省药品监督管理局                                                                                                           制表日期：2026年1月26 日序号统一社会信用代码单位全称行政强制措施实施数量（件） 行政强制执行实施数量（件）合计 行政机关强制执行申请法院强制执行查封场所、设施或者财物扣押财物 冻结存款、汇款其他行政强制措施加处罚款或者滞纳金划拨存款、汇款拍卖或者依法处理查封、扣押的场所、设施或者财物排除妨害、恢复原状代履行其他强制执行方式111510000MB1808933T四川省药品监督管理局600000000039合计600000000039填表说明：1.行政强制措施实施数量的统计范围为统计年度1月1日至12月31日期间作出“查封场所、设施或者财物”、“扣押财物”、“冻结存款、汇款”或者“其他行政强制措施”决定的数量。2.行政强制执行实施数量的统计范围为统计年度1月1日至12月31日期间“加处罚款或者滞纳金”、“划拨存款、汇款”、“拍卖或者依法处理查封、扣押的场所、设施或者财物”、“排除妨碍、恢复原状”、“代履行”和“其他强制执行方式”等执行完毕或者终结执行的数量。3.其他强制执行方式，如《城乡规划法》规定的强制拆除；《煤炭法》规定的强制停产、强制消除安全隐患；《金银管理条例》规定的强制收购；《外汇管理条例》规定的回兑等。4.申请法院强制执行数量的统计范围为统计年度1月1日至12月31日期间向法院申请强制执行的数量，时间以申请日期为准。

行政相对人名称 扬州欧丝曼日化有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 91321016MA1NYB8D2D 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 顾俊 法定代表人证件类型 身份证 法定代表人证件号码 321************12 证件类型 证件号码 行政处罚决定书文号 苏药监扬处罚〔2025〕45号 违法行为类型 生产经营不符合技术规范的化妆品的行为，违反了《化妆品监督管理条例》第六条规定。 违法事实 扬州欧丝曼日化有限公司，生产经营不符合技术规范的化妆品的行为，违反了《化妆品监督管理条例》第六条规定，依据《中华人民共和国行政处罚法》第二十八条第一款、《化妆品监督管理条例》第六十条第二项规定，应予处罚。 处罚依据 依据《中华人民共和国行政处罚法》第二十八条第一款、《化妆品监督管理条例》第六十条第二项规定。 处罚类别 罚款；没收违法所得 处罚内容 没收违法所得陆佰叁拾元整；处以罚款叁万元整 罚款金额（万元） 3.0 没收违法所得没收非法财物的金额（万元） 0.063 暂扣或吊销证照名称及编号 处罚决定日期 2026/01/20 处罚有效期 2026/07/20 公示截止期 2029/01/20 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

近日，国家药监局综合和规划财务司下发了《国家药监局综合司关于2025年检验能力验证计划满意结果的通报》。通报结果指出，省药检所2025年度参加的“胖大海中黄曲霉毒素B1残留量测定”、“药品比旋度测定”、“塑料膜的透湿性”、“葡萄糖酸锌含量测定”、“化妆品霉菌和酵母菌计数”、“化妆品中二噁烷的测定”等6项国家药监局药品、化妆品领域能力验证，全部获得“满意”结果。2025年度，省药检所积极参加国内外权威机构组织的能力验证活动共20项，均获得“满意”结果，药品化妆品各领域的技术能力得以充分验证，检验检测工作的质量控制得到良好保证。其中，参加LGC组织的能力验证“HPLC Analysis,1 sample and reference standard（PH092：Assay。PH094：related substance teast）”是省药检所连续第4年参加国际能力验证，全部获得“满意”结果。另外，省药检所成功组织开展“药品pH值测定的实验室比对”、“药品中大肠埃希菌检验实验室比对”、“薄层色谱鉴别实验室间比对”、“HPLC法测定制剂中天麻素含量实验室间比对”等全省范围实验室比对活动4项，全省9家药品检验机构及128家生产企业质量管理实验室参加比对。通过能力验证和实验室比对活动，省药检所检验工作中存在的技术风险能够被有效识别和控制，检验检测技术能力得以持续提升，质量管理得到进一步完善，实验室的整体运行效率进一步提高，同时，获得的多项“满意”结果也进一步保证了检验检测结果的准确性和可靠性。

按照国家医保局《医药价格和招采信用评价的操作规范（2025版）》第7.1.6条规定，现将近期新增医药企业信用评级结果公告如下:序号企业名称评定结果失信等级时效起止日期1郑州视思明商贸有限公司失信2026.1.1-2029.1.12河南方辰商贸有限公司失信2026.1.1-2029.1.13河南豪群商贸有限公司失信2026.1.1-2029.1.14苏州市利航医疗器械有限公司失信2026.1.1-2029.1.12026年1月27日

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Tony Serafini-LamannaPresident of DiagnosticsMeridian Bioscience, Inc3471 Riverhills Dr.Cincinnati,OH45244United StatesTony.Serafini-Lamanna@meridianbioscience.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 720826December 22, 2025Dear Mr. Serafini-Lamanna:During an inspection of your firm, Magellan Diagnostics, Inc. located in North Billerica, MA from August 5, 2025, through August 26, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures in-vitro diagnostics (IVD) kits that measure blood lead levels, including the LeadCare II Blood Lead Analyzer and Test Kit. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.Quality System Regulation ViolationsThis inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21,Code of Federal Regulations(CFR), Part 820.We received responses from Vernon Brown Director – Quality Assurance and Regulatory Affairs, Meridian Biosciences, Inc. dated September 17, 2025, October 3, 2025, October 17, 2025, November 14, 2025, November 26, 2025, and December 12, 2025, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address your responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:1. Failure to establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a).Specifically, your firm failed to follow its CAPA procedure, SOP 128, Rev 15, Effective March 27, 2025, including opening CAPAs as required by your procedure. Section 2 of this SOP indicates CAPA’s can arise from “A systemic issue identified through trend monitoring.” For example:A) Your firm failed to open a CAPA in October 2024, when you began trending an increase in patient false positive complaints (PATFP) associated with the use of certain third-party ((b)(4)) collection tubes used with your LeadCare II Blood Lead Test Kit. From October 7, 2024, to August 14, 2025, you identified approximately 179 of these PATFP complaints. We are also aware that you did not take these complaints into account with a previous CAPA 1288 which was initiated on May 3, 2023, to address increased patient false positive complaints (PATFP) for the LeadCare II Blood Lead Test Kit. This CAPA 1288 was closed out on May 22, 2025, noting that “current complaint trending reports confirm that the PATFP complaint rate has reached a steady state.” However, your firm received 31 complaints of false positives after this date and did not take any further action, such as the opening of a new CAPA, as required by your procedure.B) Your firm failed to open a CAPA to address at least(b)(4)out-of-range control complaints ("COORLO") received for your LeadCare II Blood Lead Test Kit from June 22, 2021, to July 2025.We reviewed your firm’s responses and concluded they are not adequate. We understand that you have revised product labeling to indicate that the customer must use only the capillary tubes included in the LeadCare II Blood Lead Test Kit for blood collection and that you plan to send customers a letter to inform them of this update. Please be aware that this action would require a report to be submitted to FDA as required by 21 CFR 806. However, your firm has not provided copies of the CAPAs opened in response to this observation to demonstrate your proposed corrective actions will be effective, nor did it indicate that it will be performing any retrospective review of previous complaints or trends to ensure CAPAs have been opened appropriately and as required by your procedure.2. Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented, as required by 21 CFR 820.30(c).For example, your firm failed to establish design inputs for the Level 1 and Level 2 Controls used in LeadCare II Blood Lead Testing Systems as required by your Design Control Procedure, SOP 131, Revision 13, Effective Date June 6, 2021. The Instructions for Use for LeadCare II Blood Lead Testing System states that Level 1 and Level 2 controls are intended "to verify system performance and accuracy before testing patient results." Yet, the Design Requirement Matrix, Rev G, dated July 1, 2020, which was provided as the latest specification for LeadCare II testing system, fails to establish specific and separate design requirements for the Level 1 or Level 2 Controls that are part of the LeadCare II testing system.We reviewed your firm’s responses and concluded they are not adequate. Your firm indicated that a CAPA will be opened to evaluate the level 1 and 2 controls and will also include a retrospective review of complaints to further evaluate the issue. However, your firm did not provide a copy of the CAPA to demonstrate your proposed corrective actions will be effective. Also, your response did not include a timeline for revising your design documents nor any plans for assessing your design control program to mitigate the above observation.3. Failure to establish and maintain procedures for validating the device design. Design validation shall be performed under(b)(4)operating conditions on(b)(4)production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF, as required by 21 CFR 820.30(g). For example:A) Your firm did not validate the cleaning and decontamination instructions written in the Instructions for Use (IFU) for Blood Lead Testing Systems - LeadCare II, LeadCare Ultra, and LeadCare Plus Analyzers.B) Your firm failed to adequately establish your Risk Management Procedure SOP 159, Rev 08, dated March 12, 2025, which requires the Risk Management File to be updated periodically or when previously unrecognized hazards are present. For example:o Your firm failed to update your risk files for your LeadCare II test system, after becoming aware of an increase in false positive complaints associated with the use of(b)(4)Tubes from October 7, 2024, to August 14, 2025. Specifically, your DFMEA dated December 1, 2022, PFMEA dated November 5, 2020, and UFMEA dated June 18, 2020, were not updated to include this previously unrecognized hazard.o Your firm failed to update your risk files for their LeadCare II test system, after becoming aware of two separate labeling control failures during manufacturing in March of 2023 and again in May of 2024 that resulted in mislabeled products being distributed. Specifically, the PFMEA dated November 5, 2020, was not updated to identify any risks associated with the mislabeling of products being released.We reviewed your firm’s responses and concluded they are not adequate. Your firm indicated it will validate the cleaning process and expect this to be completed by January 9, 2026. Your firm’s response noted a CAPA will be opened for review and revision of the risk management files, but did not provide any details, including a copy of the CAPA to demonstrate your proposed corrective actions will be effective. Also, the responses did not include a plan to perform any retrospective review of ECO’s to ensure risk management files will be updated appropriately.4. Failure to validate a process with a high degree of assurance and approved according to established procedures, when the results of a process cannot be fully verified by subsequent inspection and test. The validation activities and results, including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated, shall be documented, as required by 21 CFR 820.75(a). For example:A) Your firm failed to have validation data to demonstrate how calibration verification with only(b)(4)of data can ensure reliable device performance across the reportable range for a diagnostic device. Your calibration verification procedure 65055, allows exclusion of up to(b)(4)of test results when they exceed the reportable range. This procedure includes instructions for operators to "leave blank" any "High" results and exclude "obvious outliers or contaminated samples," and if remaining data fails bias specification, it allows(b)(4)calibration adjustments.B) Your firm failed to validate the revised manufacturing process which included new acceptance criteria to include(b)(4), to demonstrate consistent manufacturing capability. Engineering Change Order (ECO) 7378 was initiated on June 30, 2023, to “Update Procedures for "LC II Sensor Calibration Verification" (Document Reference 650055) and "LeadCare Ultra Sensor Calibration Verification Procedure" (Document Reference 65064) to include release requirements for(b)(4)and(b)(4)based on the(b)(4)testing data obtained.” The ECO noted this process change was considered a low risk, and no additional validation was performed, even though this is critical acceptance criteria.We reviewed your firm’s responses, and concluded they are not adequate. Your responses indicated CAPAs were opened to address the above items; however, they did not provide a copy of the CAPAs to demonstrate your proposed corrective actions will be effective or a plan to ensure re-validation is performed, as necessary, when manufacturing operations are revised, including anytime acceptance criteria is modified.5. Failure to establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented, as required by 21 CFR 820.80(b).For example, your firm failed to establish adequate incoming inspection procedures for capillary collection tubes used with your blood lead testing kits. The current procedure requires a sample of(b)(4)tubes from lot sizes of(b)(4)units per(b)(4)for packaging verification only. Your Incoming Inspection Procedure, SOP 105, Rev 10, Effective Date April 18, 2025, does not specify inspection of any critical quality attributes for these capillary tubes.We reviewed your firm’s responses and the adequacy cannot be determined at this time. We understand that you plan to revise specifications for LCII Blood Collection Capillary – Plungers Kit, and plan to initiate incoming inspection on these components, including testing the tubes for lead, however, these revisions are still in progress. We will need to verify that your firm is performing sufficient inspections to ensure these components meet their required specifications.6. Failure to have written sampling plans that are based on a valid statistical rationale. Each manufacturer shall establish and maintain procedures to ensure that sampling methods are adequate for their intended use and to ensure that when changes occur the sampling plans are reviewed. These activities shall be documented, as required by 21 CFR 820.250(b).For example, your firm failed to follow your Statistical Methods & Analysis of Data Procedure, SOP 139, Rev 04, Effective Date November 16, 2020, Section 6.5, which requires adequate sample size justification for process/product verification/validation/test method validation studies. Validation testing performed on August 30, 2023, to validate mold modification of caps through(b)(4)Caps (P/N(b)(4)), inspected only 10 caps from Cavity(b)(4)and Cavity(b)(4)(5 each) without describing lot size or providing valid statistical rationale for the sample size chosen.We reviewed your firm’s responses and the adequacy cannot be determined at this time. You indicated a CAPA was opened to review your procedures related to statistical evaluation, but you did not provide any additional documentation, including a copy of the CAPA to demonstrate your proposed corrective actions will be effective.Medical Device Reporting (MDR) ViolationsOur inspection also revealed that your firm’s LeadCare Plus Blood Lead Testing Systems are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 ‐ Medical Device Reporting. Significant violations include, but are not limited to, the following:Failure to report to us the information required by § 803.52 in accordance with therequirements of § 803.12(a), no later than 30 calendar days after the day that your firm receives or otherwise become aware of information, from any source, that reasonably suggests that a device that your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2). For example:The information included for Complaint #MAG-CC-05942 describes an event where the pediatric patient experienced a false negative result while using your firm’s LeadCare Plus blood lead testing system, as a result of a device malfunction (e.g., corroded sensor pin). We believe this malfunction resulted in the device’s failure to perform its essential function and compromise the device’s diagnostic effectiveness and would be likely to cause or contribute to a death or serious injury. There’s no information included for the complaint indicating that the malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur. Accordingly, the complaint represents an MDR-reportable malfunction, as defined in 21 CFR 803.3. Your firm became aware of the event on October 30, 2023, and firm failed to submit the MDR within the required 30-calendar-day timeframe.The information included for Complaint # MAG-CC-06971, describes a malfunction (i.e., analyzer emitting a burning smell) involving your firm’s LeadCare Plus Blood Lead Testing System. Your firm became aware of MAG-CC-06971 on July 17, 2024, and submitted a malfunction MDR for the event. FDA received the corresponding MDR# 1218996-2025-00006 on January 29, 2025, which is beyond the 30-calendar day timeframe after becoming aware.The adequacy of your firm’s responses cannot be determined at this time. Your firm has not yet submitted an MDR for complaint #MAG-CC-05942. In addition, the response states that your firm plans to initiate a CAPA to evaluate and optimize the MDR reporting process and conduct a retrospective review to address the issue in accordance with the revised process. However, your firm has not provided documentation or evidence demonstrating that the systemic corrective actions have been fully implemented, including completion of the retrospective review, as these activities are still ongoing.Corrections and Removals ViolationsOur inspection also revealed that your firm’s LeadCare II Blood Lead Test Kits devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:Failure to submit any report required within 10 working days of initiating a correction or removal, as required by 21 CFR 806.10. For example: Magellan Diagnostics, Inc. became aware of labelling error during assembly of LeadCare II Blood Lead Test Kits, halted assembly and conducted a “Stop Shipment.” Your firm sent a customer communication titled “MEDICAL DEVICE FIELD CORRECTION” dated 5/8/2024, to notify customers that(b)(4)of the LeadCare II Testing Kit calibration button was incorrectly labeled as(b)(4), which could result in inaccurate results and patient testing could be delayed. This action meets the definition of a medical device correction or removal initiated to remedy a violation which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA within 10 working days of initiation. As of the date of the close of the inspection, August 26, 2025, you did not submit a Medical Device Report of Correction or Removal to FDA for this action.Your firm’s responses adequately satisfy this citation. Magellan Diagnostics, Inc. notified customers of the problem, initiated a medical device removal, and submitted a Report of Correction or Removal to FDA as of October 27, 2025.Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.We are requesting that you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your firm’s manufacturing and quality assurance systems relative to the requirements of the device Quality System regulation (21 CFR, Part 820). You should also submit a copy of the consultant's report, and certification by your establishment's Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant's report and that your firm has initiated or completed all corrections called for in the report. The initial certifications of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:Initial certifications by consultant and establishment – July 31, 2026Subsequent certifications – July 31, 2027, and July 31, 2028.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. 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 as part of your response.Your firm’s response should be sent via email to Gina Brackett, Assistant Director, at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 720826” when replying. If you have any questions about the contents of this letter, please contact: Karen Archdeacon, Compliance Officer at karen.archdeacon@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Barbara C. MarsdenActing DirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC: Vernon Brown, Director – Quality Assurance and Regulatory Affairs, vernon.brown@meridianbioscience.com

Delivery Method:Via EmailReference #:320-26-37Product:Drugs、Over-the-Counter DrugsRecipient:Mr. Soo Nam TanGroup Executive ChairmanFulijaya Manufacturing SDN. BHD.No. 30, Loring Makmur 13/1Taman Makmur Industrial Estate09000KulimKedahMalaysiasoonamtan@yahoo.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-26-37January 14, 2026Dear Mr. Tan:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fulijaya Manufacturing SDN. BHD., FEI 1000291174, at No. 30, Loring Makmur 13/1, Taman Makmur Industrial Estate, Kulim, Kedah, from July 14 to 18, 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 August 6, 2025 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).Your laboratory records lacked complete and original data to support the analyses performed. For example, our investigator asked for raw data for microbiological release and stability testing of your over-the-counter (OTC) drug products prior to May 2025 and your firm’s representative stated that the logbooks were not available.Reliability of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results or conditions associated with all tests. Furthermore, the lack of reliable data compromises the quality unit’s ability to exercise its function of ensuring compliance to applicable standards.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.We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action (CAPA) plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.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 microbiological test methods were appropriate to assure your drug products and components conform to appropriate standards of quality and purity. Specifically, you failed to conduct growth promotion testing of your microbiological media to assure suitability before use in release and stability testing of your drug products. Additionally, you lacked appropriate sampling and testing to ensure(b)(4)used as a component in your drug products is suitable for its intended use as you did not perform testing forBurkholderia cepacia complex(BCC).In your response, you acknowledged that your firm accepted media growth promotion testing solely based on the supplier’s certificate of analysis (CoA) without independent verification. You also acknowledged that your firm did not perform suitability testing and did not evaluate your(b)(4)system for BCC. Your firm committed to using a qualified third-party laboratory to verify the quality of growth media and to perform suitability testing, as well as initiate sampling and testing of your(b)(4)system for BCC. Your response is inadequate. Notably, your response stated that a review of internal microbial limit testing data from recent years indicates that microbial detection has been achievable, demonstrating the effectiveness of the current testing process. However, as noted in this letter, your internal microbial limit testing is flawed.The ability of microbial testing methods to detect objectionable microorganisms in the presence of each drug product must be established. Results generated using unverified or unvalidated methods may put consumers at risk.In response to this letter, provide:A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A list of chemical and microbial specifications, including test methods and date validated and/or verified, used to analyze each batch of your drug products before a batch disposition decision.o An action plan and timelines for conducting full microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.A retrospective risk assessment of prior testing to assure suitability of all growth media for the last three years of drug microbiological testing to ensure reliable microbial enumeration and appropriate identification of objectionable microorganisms.3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Your firm did not have adequate stability data to demonstrate that the quality attributes of your drug products remain acceptable throughout the labeled expiry period. Assay testing for each active ingredient in your drug products was not being performed at each of your pre-determined timepoint intervals. Furthermore, your firm did not establish appropriate limits for impurities or evaluate your drug products for the presence of impurities.Your firm’s response is inadequate. You provided accelerated stability data for your drug products, but you did not include testing for all active ingredients and impurities. For example, the stability data for your(b)(4)lacked testing for one of the active ingredients,(b)(4), and impurities.Furthermore, in a November 12, 2024 communication your firm committed to updating your stability testing procedures to require active ingredient testing. This communication was a response to a request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4).In response to this letter, provide:A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).All procedures that describe these and other elements of your remediated stability program.Use of a Contract LaboratoryDrugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as testing laboratories. FDA regards contractors as extensions of the manufacturer. For example, contract testing laboratories performing specific identity testing of drug components (e.g., the presence of(b)(4)in(b)(4)USP) must use verified USP methods.The use of ingredients contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide, particularly with(b)(4)drug products. Your firm should perform an assessment of all testing performed by contract laboratories to ensure that the methods being utilized have been appropriately validated and/or verified. See FDA’s guidance document(b)(4).You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act to ensure safety, identity, strength, quality, and purity. See FDA’s guidance documentContract Manufacturing Arrangements for Drugs: Quality Agreementsat https://www.fda.gov/media/86193/download.Quality SystemsYour 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 assist your firm in meeting CGMP requirements. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.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. 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 Fulijaya Manufacturing SDN. BHD., No. 30, Loring Makmur 13/1, Taman Makmur Industrial Estate, Kulim, Kedah, Malaysia 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 1000291174 and ATTN: Ernest Bizjak.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research