经昆明市市场监督管理局、红河州市场监督管理局、昭通市市场监督管理局和临沧市市场监督管理局等调查证实，7名执业药师存在“挂证”行为，云南省执业药师注册中心依据《执业药师注册管理办法》（国药监人〔2021〕36号）规定，将“挂证”执业药师的不良信息录入全国执业药师注册管理信息系统“奖惩记录”栏，三年内不予注册，现予通告。姓名资格证号注册证号朱*龙2017026530262017533661000297531220011443刘*丹20211002653000000994531224260069施*丹ZZ00387456532222250172樊*ZY00333362531222290030张*艳2017026530262015533608001419531319030245段*玲ZY00502576531219010587敖*英201810026530000726531224090199云南省药品监督管理局 2026年1月14日

经昭通市市场监督管理局调查证实，3名执业药师存在“挂证”行为，云南省执业药师注册中心依据《执业药师注册管理办法》（国药监人〔2021〕36号）规定，撤销其《执业药师注册证》，将“挂证”执业药师的不良信息录入全国执业药师注册管理信息系统“奖惩记录”栏，三年内不予注册，现予通告。姓名资格证号注册证号注册单位陆*梅201810026530001551531221060147镇雄县三佳大药房二店邵*君ZY00334299531225060601镇雄县利康药房刘*20221102653000003045531225060047镇雄县新春医药有限公司三店 云南省药品监督管理局 2026年1月14日

江西大成医疗用品有限公司报告，由于医疗器械监督抽检平均装量不合格。等原因，江西大成医疗用品有限公司对其生产的医用疤痕凝胶(注册备案号:赣械注准20252140019)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.pdf2026年1月14日

　　根据《广东省食品药品监督管理局关于注销的管理规定》（粤食药监法【2013】26号），我局已依法注销吴川市大山江顿位达琼药店《药品经营许可证》。现予以公布。序号许可证号许可证标明的有效期限企业名称企业负责人注销原因注销日期1粤DB75911032026-4-29吴川市大山江顿位达琼药店潘军辉企业申请2026.01.14湛江市吴川市市场监督管理局2026年1月14日

重庆喜领医药科技有限公司、重庆长胜堂医药有限责任公司、重庆鑫宝医药有限公司因终止药品经营，经企业申请，依据《中华人民共和国行政许可法》相关规定、《药品经营和使用质量监督管理办法》第二十七条的规定，我局拟注销其《药品经营许可证》，证书内容详见附件。现予公示，请社会各界予以监督，公示日期自2026年1月13日至2026年1月19日，如公示期内无相关单位或个人提出异议，我局将正式注销其《药品经营许可证》。　　监督电话：023-60353705　　传真：023-60353733　　通讯地址：重庆市两江新区食品城大道27号　　邮编：401120　　附件：拟注销的许可证内容   　　　　　　　　　　　　　　　　　　　　　　　　　　重庆市药品监督管理局                              　　　　　　　　　　　　　　　　　　　　　　　　　　 2026年1月13日附件拟注销的许可证内容序号企业名称经营地址社会信用代码法定代表人主要负责人许可证名称许可证编号仓库地址经营范围1重庆喜领医药科技有限公司重庆市经开区长生桥镇茶园新城区世纪大道99号A栋1-6层（自编号103、104室）91500108MAC7J6347Y王涛王涛药品经营许可证渝BA023000032重庆市南岸区玉马路93号1栋3楼2号（委托重庆润方医药有限公司储存配送）化学药、中成药、中药饮片2重庆长胜堂医药有限责任公司重庆市石柱土家族自治县下路镇银子洞路1号（银湖丽景）第1幢负1-仓库（自编：B区）91500240MA61CGQ895赵清林赵清林药品经营许可证渝AA023000166重庆市石柱土家族自治县下路镇银子洞路1号（银湖丽景）第1幢负1-仓库（自编：A区）中药饮片,中成药,化学药,生物制品3重庆鑫宝医药有限公司重庆市经开区长生桥镇茶花路5号（自编号1幢物理层2层1-3号）91500108MABT7JQ5XP韦龙韦龙渝AA023000294重庆市经开区长生桥镇茶花路5号2幢物理层2-1号化学药、中成药

根据《放射性药品管理办法》、《关于开展换发工作的通知》（国食药监安〔2003〕199号）、江西省核发《放射性药品使用许可证验收标准》（赣药监规〔2024〕6号）的规定，经我局组织专家对赣州市人民医院的申请进行审查和现场检查，认为符合放射性药品使用许可证的许可要求，现予以审查公示（详见附件）。公示期自2026年1月13日至2026年1月19日，共计7天。请社会各界予以监督。监督电话：0791-88121017地址：南昌市北京东路1566号邮政编码：330029 电子邮件：jxsypjyc@126.com特此公示。江西省药品监督管理局2026年1月13日附件：江西省核发放射性药品使用许可证审查公示（202601号）序号企业名称单位地址申请事项及类别法定代表人放射性药品科负责人备注1赣州市人民医院赣州市章贡区梅关大道16号赣州市人民医院南院肿瘤医学楼一楼申请核发《放射性药品使用许可证》（第四类）戴辉廖忠剑仅限配制使用 相关信息

行政处罚决定书文号：沈皇市监处罚﹝2025﹞108号处罚类别：罚款;没收违法所得处罚决定日期：2025-07-04处罚内容：1、没收违法所得11.00元； 2、罚款5000.00元。罚款金额(万元)：0.5违法行为类型：行政违法违法事实：销售阿托伐他汀钙片未能提供进货票据。处罚依据：依据《药品管理法》第一百二十九条处罚机关：沈阳市皇姑区市场监督管理局处罚机关统一社会信用代码：11210105MB05402774数据来源单位：沈阳市皇姑区市场监督管理局数据来源单位统一社会信用代码：11210105MB05402774

Delivery Method:VIA UNITED PARCEL SERVICE AND VIA E-MAILReference #:25-HFD-45-12-03Product:DrugsRecipient:Purushothaman Damodara Kumaran, M.D.Senthil Specialty HospitalNumber 10 and 12, Thillai Maistry StreetPondicherry605001PuducherryIndiaIssuing Office: Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 25-HFD-45-12-03Dear Dr. Damodara Kumaran:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at Senthil Specialty Hospital in Pondicherry, Puducherry, India, between January 20 and 24, 2025. The investigator representing FDA reviewed your conduct of a clinical in vivo bioequivalence study (Protocol(b)(4), “(b)(4)”) of the investigational drug(b)(4), performed for(b)(4).This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, the FDA investigator presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your February 14, 2025, written response to the Form FDA 483.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated February 14, 2025, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312), governing the conduct of clinical investigations and the protection of human subjects.1We wish to emphasize the following:You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plan for Protocol(b)(4)required you to collect safety assessments, including hematology and pulmonary function tests, every week after the first dose of investigational drug in Period I (during the study washout period) and for six weeks after dosing in Period II (that is, on Day 8, Day 15, Day 22, Day 29, Day 35, and Day 42 of each dosing period).You failed to adhere to these requirements. Specifically, for Subjects(b)(6), and(b)(6), hematology and pulmonary function safety assessments were not completed after investigational drug dosing on Day 8, Day 22, and Day 35 during both Period I and Period II, as required by the protocol. As a result, half of the protocol-required safety assessments for these subjects were not completed during the study.In your February 14, 2025, written response to the Form FDA 483, you stated that you modified the study visit schedule for pragmatic reasons, including subjects’ needs, their travel commitments, and their ongoing treatment plans. You stated that the deviation considered the established late onset of myelosuppression, and that the selection of subjects was based on their historical tolerability of(b)(4). You also stated that you employed regular follow-ups, including telephone consultations, to identify and promptly address any adverse events. Furthermore, you stated that this monitoring strategy was tailored to ensure maximum oversight of subject safety, which was discussed and planned during the study initiation visit, and that the sponsor and ethics committee remained aware of these protocol deviations.While we acknowledge your statement that you purposely deviated from the investigational plan to limit protocol-required study visits for pragmatic reasons, and that the sponsor remained aware of these protocol deviations, you did not provide evidence to demonstrate that the sponsor approved of such actions before you deviated from the investigational plan. You also did not provide evidence of the telephone consultations you stated that you employed in regular follow-ups of subjects, to identify and address adverse events.Furthermore, your written response is inadequate because you did not provide information about any completed or proposed corrective actions that would prevent similar violations in the future. For example, you did not provide details about how you will ensure that ongoing and future clinical investigations at your clinical research site will be conducted in compliance with the investigational plan and applicable FDA regulations. Without this information, we are unable to undertake an informed evaluation of your response.We emphasize that, as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data. The investigational drug,(b)(4), may cause subjects to experience certain adverse events, such as myelosuppression, which can lead to fatal infections and bleeding.(b)(4)may also cause subjects to experience pulmonary toxicity (lung damage), characterized as lung infiltrates and/or fibrosis. To minimize these risks, the protocol required hematology and pulmonary function tests to assess subjects’ bone marrow and lung functions at baseline and at weekly safety monitoring visits after the receipt of the investigational drug. Your failure to conduct the study in accordance with the investigational plan – and specifically, your failure to ensure that Subjects(b)(6)’s bone marrow and lung functions were monitored at the study-required intervals after receiving the investigational drug – raises concerns about your protection of the study subjects enrolled at your site.This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe that you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.Should you have any questions or concerns about this letter or the inspection, please email FDA at CDER-OSI-Communications@fda.hhs.gov. Your written response and any pertinent documentation should be addressed to:Brittany L. Garr, MPHBranch ChiefCompliance Enforcement BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationBuilding 51, Room 535210903 New Hampshire AvenueSilver Spring, MD 20993Sincerely yours,{See appended electronic signature page}David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration__________________1In accordance with 21 CFR 320.31(c), the provisions of 21 CFR part 312 are applicable to this bioequivalence study because Protocol(b)(4)was conducted under an Investigational New Drug application (IND).--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------DAVID C BURROW12/22/2025 12:05:47 PM

行政处罚相对人类别:法人及非法人组织行政处罚决定书文号:穗云市监处罚〔2026〕71号处罚类别:罚款;没收违法所得、没收非法财物罚款金额(万元):1没收违法所得、没收非法财物的金额(万元):0.40275暂扣或吊销证照名称及编号:违法事实:根据抽检不合格报告线索，2025年12月15日，我局执法人员依法到当事人位于广州市白云区龙归街夏良东路22号的住所进行检查，现场送达《广东省药品检验所检验报告》（No：2025A16199），报告显示，标识为当事人生产的“上方同庆氨基酸净颜洁面乳（批号：20250724、限用日期：20280723、规格：40g）”产品：检验报告结论显示该产品“苯氧乙醇”项目不符合规定，检验结论为不合格。当事人在现场签收了上述抽检不合格报告，承认上述检验报告中对应名称批次的产品是其生产的，其对检验结果无异议，未提出复检申请。执法人员对当事人车间、仓库、办公室、留样室等进行检查，现场在留样室发现上述产品的4盒留样；当事人在执法人员见证下现场对4盒留样产品进行了销毁处理。执法人员在当事人办公室调取并复印上述不合格产品的生产批记录和销售单据等资料。因当事人涉嫌生产不符合化妆品安全技术规范的化妆品，执法人员对其立案调查。经查明，当事人于2025年7月24日灌装生产“上方同庆氨基酸净颜洁面乳（批号：20250724、限用日期：20280723、规格：40g）”产品2700盒，其中5盒用于自检，6盒被广东省药品检验所用于抽检，留样4盒于2025年12月15日在我局执法人员的见证下现场销毁；其余2685盒以1.5元/盒的价格售出。上述产品当事人客户提供，包材成本为0.353元/盒，双方约定以4027.5元（1.5元/盒*2685盒）的金额付款。我局认定当事人生产的上述批次涉案产品违法所得为4027.5元，货值1.853元/盒，总货值共计5003.1元。处罚依据:①《化妆品监督管理条例》（2021年1月1日起施行）第六十条：有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处1万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上3倍以下罚款，10年内禁止其从事化妆品生产经营活动；构成犯罪的，依法追究刑事责任：　　（一）使用不符合强制性国家标准、技术规范的原料、直接接触化妆品的包装材料，应当备案但未备案的新原料生产化妆品，或者不按照强制性国家标准或者技术规范使用原料；　　（二）生产经营不符合强制性国家标准、技术规范或者不符合化妆品注册、备案资料载明的技术要求的化妆品；　　（三）未按照化妆品生产质量管理规范的要求组织生产；　　（四）更改化妆品使用期限；　　（五）化妆品经营者擅自配制化妆品，或者经营变质、超过使用期限的化妆品；　　（六）在负责药品监督管理的部门责令其实施召回后拒不召回，或者在负责药品监督管理的部门责令停止或者暂停生产、经营后拒不停止或者暂停生产、经营。②《广东省化妆品安全条例》（2019年7月1日起施行）第五十二条：违反本条例第十三条第二项、第四项、第五项规定，超量或者超范围使用国家规定的化妆品限用原料生产化妆品，使用超过使用期限、废弃、回收等不符合国家有关标准或者处罚内容:当事人生产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》第六条第二款“化妆品生产经营者应当依照法律、法规、强制性国家标准、技术规范从事生产经营活动，加强管理，诚信自律，保证化妆品质量安全。”及第二十九条第二款“化妆品注册人、备案人、受托生产企业应当按照化妆品注册或者备案资料载明的技术要求生产化妆品。”的规定的规定，依据《化妆品监督管理条例》第六十条第（二）项“有下列情形之一的，由负责药品监督管理的部门没收违法所得、违法生产经营的化妆品和专门用于违法生产经营的原料、包装材料、工具、设备等物品；违法生产经营的化妆品货值金额不足1万元的，并处1万元以上5万元以下罚款；货值金额1万元以上的，并处货值金额5倍以上20倍以下罚款；情节严重的，责令停产停业、由备案部门取消备案或者由原发证部门吊销化妆品许可证件，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处以其上一年度从本单位取得收入的1倍以上3倍以下罚款，10年内禁止其从事化妆品生产经营活动；构成犯罪的，依法追究刑事责任：（二）生产经营不符合强制性国家标准、技术规范或者不符合化妆品注册、备案资料载明的技术要求的化妆品；”的规定，决定对当事人作出如下处罚：一、没收违法所得4027.5元；二、处罚款10000元。上述罚没合计14027.5元。另，根据《中华人民共和国行政处罚法》第二十八条第一款“行政机关实施行政处罚时，应当责令当事人改正或者限期改正违法行为。”的规定,责令当事人立即改正生产不符合技术规范的化妆品的行为。违法行为类型:化妆品生产企业违法行为行政相对人名称:广州市宝康医药生物科技有限公司行政相对人代码:统一社会信用代码组织机构代码工商登记码税务登记号事业单位证书号社会组织登记证号91440101MA5B6QJ35M法定代表人:付卫国处罚决定日期:2026-01-09公示截止期:2029-01-09处罚机关:广州市白云区市场监督管理局数据来源单位:广州市市场监督管理局（广州市知识产权局）

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Doug ShaverChief Executive OfficerASP Global, LLC. dba Anatomy Supply Partners, LLC.7800 Third Flag PkwyAustell,GA30168-7657United Statesdoug.shaver@aspglobal.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 718444December 9, 2025Dear Mr. Shaver:During an inspection of your firm located in Austell, Georgia from July 28, 2025, through August 1, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures Safe-T-Fill Micro Capillary Collection System. 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 a response from Tracy A. Weldon, Vice President of Quality and Regulatory dated August 22, 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 this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following1. Failure to adequately establish procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50. Your firm failed to adequately implement supplier management procedures to ensure that products purchased from your critical supplier and manufacturer of Safe-T-Fill Capillary Collection Tubes,(b)(4), conform to specified requirements.For example, your supplier management procedures were not adequately implemented to ensure that product purchased from critical supplier and manufacturer of Safe-T-Fill Capillary Collection Tubes,(b)(4), provided product that conform to specified requirements. Your firm did not verify the product’s ability to meet specified needs or(b)(4)ability to produce products that do not interfere with(b)(4)lead analyzers, a common lead testing technique. There were 26 complaints reported to ASP Global from October 2024 to April 2025 (Complaints 2024-01 through 2025-18) related to false positive lead results when Safe-T-Fill EDTA tubes were used with Magellan LeadCare systems. The ongoing investigation in CAPA-02 and SCAR-339 identified that(b)(4)uses(b)(4)versus(b)(4)to(b)(4)the capillary tubes, and(b)(4)may contain higher levels of(b)(4)impurities from the(b)(4). The investigation noted that(b)(4)behaves similarly to lead when using(b)(4), which is used by the Magellan LeadCare systems, causing false positive results. Your firm’s procedure "Supplier Management", Q-P-035, Rev. 3, 08/01/2022, Section 3.1 states, "The purpose is to ensure that ASP Global’s suppliers are selected, qualified, approved, and monitored based upon risk-based practices and regulatory requirements to ensure consistent final product quality through the utilization of qualified suppliers and agreed upon requirements and/or specifications." The following deficiencies were noted during our inspection,A.(b)(4)supplier evaluations using Form Q-F-256 were not performed for(b)(4)in(b)(4)and(b)(4)as required. Section 10.4.4.1 of the Supplier Management SOP requires "Supplier Evaluations are conducted for Tier(b)(4)suppliers once every(b)(4)... Q-F-256 On-Going Supplier Evaluation Form is used to document the supplier evaluation."B. An on-site audit of(b)(4)was not performed in(b)(4)as required, with no documented justification provided. Additionally, multiple other Tier(b)(4)suppliers were not audited on the required(b)(4). The Supplier Management SOP, Q-P-035, Rev. 3, Section 10.5.3.1 states "Tier(b)(4)contract manufacturers of finished devices to(b)(4)specifications require on-site audits at a minimum of once every(b)(4)unless otherwise specified."C.(b)(4)was audited by FDA in(b)(4)and received four observations, but ASP Global was not notified until April 29, 2025, after(b)(4)was placed on Import Alert, despite working closely with(b)(4)on SCAR-339 from February to March 2025. The ASP/(b)(4)Quality Agreement, Section 2.3, Page 6 of 15, states "(b)(4)shall notify ASP in writing within(b)(4)if any of the following occurs: (c)(b)(4)becomes aware of any inspection or audit findings that affect safety, effectiveness, conformity, or availability of product."D. ASP Global did not verify that(b)(4)maintains adequate design history files (DHF) for the Safe-T-Fill products during the supplier evaluation period (12/2022) following the acquisition of 510(k)’s K981973 and K983517 from(b)(4). The Quality Agreement states in Section 2.2 that "(b)(4)will maintain 'Design History Files' with all design inputs, outputs and changes," but ASP Global was unable to provide the full DHF during the inspection due to deficiencies noted during(b)(4)FDA inspection.E. ASP Global did not review Safe-T-Fill product information to determine if specifications adhered to original 510(k) clearances or if a new 510(k) was required for changes to the originally cleared products. The 300 μL size Safe-T-Fill tubes have been marketed since 2001 without proper evaluation of whether a new 510(k) clearance is required, as only 125 μL, 150 μL, and 200 μL tubes were cleared in the original 510(k)s K981973 and K983517 in 1998. Product catalogs and labels show 300 μL tubes being actively marketed.Your firm’s failure to have adequate purchasing controls to include design controls for the Safe-T-Fill product demonstrates significant deficiencies in the design and manufacture of these products. The distribution of device without appropriate design controls throughout the product development lifecycle may pose patient safety risks and potentially lead to inappropriate medical interventions.Your firm's responses dated August 22, 2025, and October 22, 2025, are inadequate. Your firm's commitment to implementing corrective actions is acknowledged; however, the response does not include adequate details and supporting documentation regarding ongoing corrective actions. Your response lacks sufficient detail and documentation for the following proposed corrective actions: (1) development of effectively implemented supplier controls based upon supplier history and product risk assessment, (2) ensuring suppliers are managed by adequately trained and resourced personnel, (3) development of meaningful audit criteria and schedules for conducting periodic audits of appropriately identified Tier(b)(4)suppliers, (4) development of robust integration procedures to properly assess firms during integration for compliance with all regulatory requirements, including legacy product changes and associated clearances, (5) development of procedures to properly evaluate and audit suppliers once acquired, and (6) ensuring creation of necessary work instructions to ensure proper adherence to new and existing procedures.While your response includes a revision of the(b)(4)Supplier Quality Agreement (SQA) to require design verification, design validation, risk management, and design transfer, you have not provided sufficient detail or records regarding implementation of these corrective actions. As the owner of the SAFE-T-FILL tubes associated with 510(k) numbers K981973 and K983517, you have not demonstrated how these corrective actions will ensure compliance with all requirements under 21 CFR 820.30. The SAFE-T-FILL Capillary Blood Collection System is indicated for drawing blood via capillary action from finger or heel stick placement in a microtube for obtaining blood samples for diagnostic testing. Lead testing represents one of many common laboratory tests performed in clinical laboratories.Your response fails to describe how you will remediate design control records, including the design history file (DHF), to ensure that critical specifications for your firm's SAFE-T-FILL Capillary Blood Collection System cleared 510(k)s meet user needs and the intended use of the device. Your response notes that(b)(4)has been disqualified as a supplier; however, it remains unclear how they will provide supplied services such as design control remediation activities as part of your firm's corrective action plan to FDA 483 Inspection Observations. In addition, your response does not describe how these deficiencies impact other supplied product contract manufacturered and designed by(b)(4)such as SAFE-T-FILL Capillary Blood Collection System; Plasma – Chemistry; Serum – Chemistry, Glucose only; Serum – Chemistry; Blood Gas Capillary Tubes; Micro Hematocrit Tubes and other SAFE-T-FILL Capillary Blood Collection System accessories. Therefore, it does not appear you have properly evaluated(b)(4)on their ability to meet specified requirements.Your response does not address any assessment or review of purchased medical products such as class II medical devices that are further distributed by ASP Global and whether these products continue meet the original market clearance or if substantial changes have been made that require a new 510(k) submission.Medical Device Reporting (MDR) ViolationsOur inspection also revealed that your firm’s Safe-T-Fill Micro Capillary collection system 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 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:2. Failure to adequately develop, maintain, and implement written MDR procedures asrequired by 21 CFR 803.17(a)(3). For example, during the inspection, your firm presented your documents titled “Reports-Medical Device, Vigilance and Foreign Regulatory Agency”, Document# Q-P-25, Rev. 2, dated 06/17/21, and “Definitions”, Document# Q-P-067, Rev. 0, dated 08/03/2021. After collectively reviewing them as your firm’s written MDR procedure, it was noted that the procedure Q-P-25, Rev. 2, does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, Section 6.2 references a reporting timeframe for initial(b)(4)reports; however, it incorrectly specifies instructions pertaining to(b)(4)reports.Additionally, Section 6.3.5 of the procedure Q-P-25, Rev. 2, includes references to baseline reports. Baseline reports are no longer required, and we recommend that all references to a Baseline Report be removed from your firm’s MDR procedure; see: 73 Federal Register Notice 53686, dated September 11, 2008.The adequacy of your firm’s responses dated August 22, 2025, and October 22, 2025, cannot be determined at this time as various corrective actions remain ongoing. Your responses note that your firm has revised procedure Q-SOP-0031, (Reports – Medical Device, Vigilance and Foreign Regulatory Agency), and Q-Form-0045, (US Complaint Reportability Decision Tree), and that training on them is underway. You have also noted that you are in the process of revising Q-SOP-0030, Rev 3, (Complaints procedure) to include roles and responsibilities for complaint receipt, evaluation, investigation, and reporting. Additionally, you have stated that you will align Q-P-067, Rev 0 (Definitions) with the revised Q-SOP-0031, Rev 3 to ensure procedural consistency. You have indicated that personnel training will be completed(b)(4)implementation of the procedure. Finally, you have indicated that you are in the process of performing a retrospective review of complaints to address late reporting and will submit MDRs as needed.Corrections and Removals ViolationsOur inspection also revealed that your firm’s Safe-T-Fill Micro Capillary Collection System 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:3. Failure to submit a written report to FDA of any correction or removal of a device initiated to remedy a violation of the Act caused by the device which may present a risk to health, as required by 21 CFR 806.10(a). For example:On April 24, 2025, FDA issued a Safety Alert identifying the possibility of false positive lead results when using Safe-T-Fill Micro Capillary Collection Tubes with Magellan LeadCare Systems. The Safety Alert recommended not using these products together due to health risks.The inspection noted that ASP received complaints with multiple reports of falsely elevated blood lead level results when the Safe-T-Fill Micro Capillary Blood Collection Tubes were used with Magellan LeadCare test systems. On May 5, 2025, ASP Global sent correspondence to all Safe-T-Fill customers notifying them of the FDA Safety Notice. On May 16, 2025, ASP Global sent an updated communication instructing customers to follow the FDA Safety Alert and announcing that as of May 12, 2025, all sales of Safe-T-Fill Micro Capillary Blood Collection Tubes were being placed on hold until further notice.These actions constituted a correction under 21 CFR 806.2(d), as they involved modification or adjustment of device use without physical removal from the point of use to reduce a risk to health. The use of Safe-T-Fill tubes with Magellan LeadCare systems presents a risk to health, as false positive lead results prompt unnecessary confirmatory venous blood draws in primarily pediatric patients, potentially delaying accurate diagnosis and leading to improper patient management. As of the date of the FDA inspection, ASP Global failed to report this correction to FDA within 10 working days of initiation as required by 21 CFR 806.10(a)(1)(b) despite the risk to health posed by continued use of the devices with Magellan LeadCare systems and your firm's own actions to address this risk through customer communications and product hold.Your firm submitted Report of Correction or Removal number: 3004824601/08212025/R/00001 to FDA on or around September 8, 2025. This report remedies your firm’s failure to submit a Report of Correction or Removal to FDA. We also note, however, that your response dated August 22, 2025, promised to update SOP# Q-SOP-0030, Rev 3, Complaints procedure to ensure proper escalation from a quality event or trend in post market data to CAPA and HHE based on the degree of potential patient impact. This prompts the recall determination process to engage management so that appropriate actions can be initiated in a timely manner. This is targeted for completion November 2025. Completion of these tasks would support the assertion that future medical device corrections or removals will be appropriately reported to FDA.Unapproved Device ViolationsOur inspection also revealed that the EDTA Mini Capillary Collection Tube 125 μL Self-Sealing((b)(4)), EDTA Capillary Collection Tube 200 μL Self-Sealing ((b)(4)), EDTA Capillary Collection Tube 300 μL ((b)(4)), Lithium Heparin Capillary Collection 300 μL ((b)(4)), Lithium Heparin Bilirubin Capillary Collection 200 μL ((b)(4)), Serum Capillary Collection Tube 300 μL ((b)(4)), and Serum Gel Capillary Collection 300 μL ((b)(4)) are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the devices as described and marketed. These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with significant changes or modifications in the device without submitting a new premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i).4. Specifically, based on review of evidence found during the inspection, your firm has made significant changes or modifications to the original devices, the SAFE-T-FILL Capillary Collection System that were cleared under K981973 and K983517, for which your firm lacks clearance or approval. Examples include:A. For the modifications to increase the sample volume from 200 μL to 300 μL for products(b)(4), the change could introduce potential preanalytical errors associated with the specimen collection process. Higher blood volume requirement may also be more difficult in pediatric patients and any underfill specimen could introduce the risk of changing the ratio of anticoagulant to blood volume. An increase in volume requirement could also result in increased hemolysis if the users “milk/squeeze” from the source (e.g. fingers and/or heels) in order to collect more blood. Hemolysis is known to cause erroneous results in downstream laboratory tests.B. For the modifications to increase the sample volume from 200 μL to 300 μL of blood collection tubes that contain additives such as for products(b)(4)(contains liquid dipotassium EDTA) and product(b)(4)(contains lithium heparin), it is unclear if your firm has maintained the same additive-to-blood volume ratio in the 300 μL tubes compared to the 200 μL tubes. If the anti-coagulant concentration is changed, the timing and/or completeness of the clotting process will likely change. This can affect the sample quality and result in inaccurate test results.C. FDA noted that your firm has introduced product(b)(4)Lithium Heparin Bilirubin Capillary Collection 200 μL to the market. In both of your firm’s 510(k) submissions, FDA cleared several serum capillary collection tubes but not any plasma capillary collection tubes for the purpose of downstream bilirubin testing. The change from serum to plasma represents a new sample type and included the addition of lithium heparin, an additive that was not present in the original clearance and which could cause erroneous results in the downstream bilirubin testing.D. Your firm also introduced the self-sealing versions of product numbers(b)(4)and(b)(4)(to become products(b)(4)and(b)(4)respectively). The introduction of self-sealing likely requires new components/materials used to make the tubes or the stopper. Any new components or materials could potentially affect performance of downstream laboratory testing if the different materials for the tube or stopper leach substances that could interfere with downstream laboratory tests. Additionally, any leakage of blood (if the tubes did not seal appropriately as intended) pose a risk of exposure to bloodborne pathogens. Finally, new materials used in the self-sealing tubes should meet the shelf-life stability throughout the claimed shelf-life originally cleared.These changes represent significant modifications to the SAFE-T-FILL Capillary Collection System that were cleared in the original 510(k)s that could significantly affect the safety or effectiveness of the device. Therefore, submission of a new premarket notification under section 510(k) is required. For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at How to Study and Market Your Device | FDA The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.The adequacy of your firm’s responses dated August 22, 2025, and October 22, 2025, cannot be determined at this time. Your responses stated that you have stopped shipping all SAFE-T-FILL products as of May 12, 2025, and have made the decision to remove all SAFE-T-FILL Micro Capillary Blood Collection Tube products from U.S. commercial distribution due to the significant GMP violations documented in FDA’s May 2025 Warning Letter issued to Kabe. Before these products return to the market, you will conduct thorough regulatory assessments and will obtain any necessary clearance through the 510(k) process for any models that you have assessed are not covered by the original 510(k) clearances. Your firm added that there is no final decision or timeline for resuming commercialization of SAFE-T-FILL Capillary Tubes as of the October 22, 2025, response date. Your firm should provide a copy of your regulatory assessment and plans to seek new 510(k) clearances before resuming commercialization of the tubes for review.Labeling Violations5. The inspection also revealed that Micro Capillary Blood Collection - 125 μL(b)(4), Micro Capillary Blood Collection - 150 μL(b)(4), Micro Capillary Blood Collection - 200 μL(b)(4)and Micro Capillary Blood Collection - 200 μL Flat Bottom(b)(4)are misbranded within the meaning of section 502(f)(1) of the Act, 21 U.S.C. § 352(f) in that labeling fails to bear adequate directions for use. These devices do not meet the criteria for an exemption from section 502(f)(1) of the Act under 21 CFR 801 subpart D. Title 21 CFR 801.119 expressly exempts in vitro diagnostic products from section 502(f)(1) of the Act if, among other things, the device meets the requirements of 21 CFR 809.10.A. The labeling does not contain the intended use statement of the product pursuant to 21 CFR 809.10(b)(2).B. The labeling does not provide adequate descriptions of specimen collection (per 809.10(b)(7)) and does not contain a list of all materials provided, a list of materials required but not provided and times required for specific steps and proper temperature, etc. as required by 809.10(b)(8)(i) – (iii). The labeling also does not contain limitation of the procedures (per 809.10(b)(10)), bibliography section (per 809.10(b)(13)) and the date of issuance of the last revision of the labeling identified as such (per 809.10(b)(15)).C. The label and labeling do not contain the name and place of business of manufacturer, packer, or distributor as required by 21 CFR 809.10(a)(8) and (b)(14). The inner box label, inner carton label, and case label reflect(b)(4)which is the name, city, state, and zip code for the previous 510(k) holder and manufacturer for the SAFE-T-FILL Tubes. The package insert lacks any name and place of business .The adequacy of your firm’s responses dated August 22, 2025, and October 22, 2025, cannot be determined at this time. Your firm opened CAPA-000008 to address Discussion item 2. Your firm stated that you did not adequately review the labeling received from(b)(4)in 2022 against the labeling submitted in the original 510(k)s or the requirements in 21 CFR 809.10. Your firm stated that you have implemented a shipping hold on all SAFE-T-FILL product in your possession on May 12, 2025, and have begun a recall all in date products already distributed in the US due to the quality system violations found at(b)(4). Your firm has submitted 806 reports notifying FDA of this removal. Before reintroducing the SAFE-T-Fill products to the market you plan to evaluate all labeling and provide copies for review as appropriate.Your response also stated that you plan to develop procedures for review of acquired devices against applicable regulatory requirements and procedures for labeling review by December 15, 2025 and provide training by January 12, 2026. Your firm plans to conduct a retrospective review and remediation of labeling for all devices owned by ASP by March 27, 2026. Your response stated that you plan to provide details of these actions in a future response. As part of your firm’s corrective action, you should provide updated device labeling that meets all applicable requirements under 21 CFR 809.10 for review.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.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 Melissa Michurski, Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 718444” when replying. If you have any questions about the contents of this letter, please contact: Rafael Padilla, Compliance Officer at Rafael.padilla@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 Health