（2025年第2期总99期）为加强药品质量监管，保障公众用药安全，根据《中华人民共和国药品管理法》及相关法律法规，我省药品监管部门和检验机构对药品生产、经营和使用单位实施了监督抽检。现将本期药品抽检信息通报如下：一、公告情况经核查确认，净山楂等31批产品不符合规定（详见附件1）。不符合规定项目包括：杂质、总灰分、粒度、性状、水分、羧基值、乙酸龙脑酯、装量差异、重量差异、脆碎度、溶出度等。二、不符合规定药品的查处情况江西省药品监督管理局已责成相关部门对检验不符合规定的药品采取查封、扣押、暂停销售、召回等必要的控制措施，并依据相关法律法规对生产企业和被抽样单位进行查处。附件：1.药品监督抽检不符合规定信息汇总表（2025年第2期）2.不符合规定项目的小知识（2025年第2期） 江西省药品监督管理局 2025年4月25日附件2不符合规定项目的小知识1、杂质是指药物中存在的无治疗作用或者影响药物的稳定性、疗效，甚至对人体的健康有害的物质。2、总灰分测定的目的是检测中药的纯净程度。一定量的样品经炭化后放入高温炉内灼烧，使有机物质被氧化分解，以二氧化碳、氮的氧化物及水等形式逸出，而无机物质以硫酸盐、磷酸盐、碳酸盐、氯化物等无机盐和金属氧化物的形式残留下来，这些残留物即为总灰分。3、粒度是指颗粒的粗细程度及粗细颗粒的分布，用于测定药物制剂的粒子大小或限度。粒度的控制对药物的有效性、稳定性及安全性具有一定影响。4、性状记载产品的外观、臭、味、溶解度以及物理常数等，在一定程度上反映药品的质量特性。中药饮片性状项不符合规定，可能涉及药材种属偏差、炮制工艺有瑕疵、储存不当等情形。5、水分是指药品中的含水量。水分偏高通常与工艺、包装不当以及储运环境等因素有关。6、羧基值是药物成分中的一个重要参数，通过检验羧基值，可以控制药品的纯度和稳定性，从而保证其疗效和安全性。7、乙酸龙脑酯为砂仁的主要活性成分之一，通过测定乙酸龙脑酯的含量，可以反映砂仁质量的优劣。8、装量差异是药品制剂均匀性的指标之一，检查的目的在于控制单位药品装量的一致性，以确保使用剂量的准确均一，用于单剂量包装的产品检测。9、重量差异反映片剂的均匀性，检测的目的在于控制各片重量的一致性，保证用药剂量的准确。10、脆碎度检查旨在评估片剂、胶囊剂等固体制剂在运输、储存过程中的抗破碎能力，属于物理稳定性测试的重要指标，直接影响药品有效性和安全性。11、溶出度是指活性药物从片剂、胶囊剂或颗粒剂等普通制剂在规定条件下溶出的速率和程度，是片剂质量控制的一个重要指标。肠溶片在进行溶出度检查时，考虑为防止原料药物在胃内分解失效、对胃的刺激或控制原料药物在肠道内定位释放，一般考察酸中溶出量和缓冲液中溶出量。

序号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监荆门药处罚〔2025〕8号湖北夏小中医院夏文沙76412539-9生产、销售劣药当事人制剂室配制劣药百草骨炎灵片违反了《中华人民共和国药品管理法》第九十八条的规定。1、没收违法所得；2、没收劣药。《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给予处罚。当事人已于2025年4月15日主动履行完毕。湖北省药品监督管理局2025年04月10日

序号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监荆门药处罚〔2025〕1号湖北道地药材科技有限公司阮长城91420800773919297T生产销售劣药当事人生产销售中药饮片劣药蜜款冬花、炒僵蚕、土鳖虫、龙胆、白鲜皮违反了《中华人民共和国药品管理法》第九十八条第三款的规定。1、没收违法所得和劣药；2、罚款。《中华人民共和国药品管理法》第一百一十七条第一款和《中华人民共和国行政处罚法》第三十二条第（五）项的规定。当事人已按分期缴纳罚款通知要求，分三期主动履行完毕。湖北省药品监督管理局2025年01月24日

省药监局认真落实全省深化“三个年”活动部署要求，于近日制定出台《全面推行服务型执法的实施方案》（以下简称《方案》），进一步规范行政执法行为，提高执法质效，优化营商环境，促进药品监管高质量发展。《方案》明确9条具体措施，将服务贯穿于药品行政执法“事前、事中、事后”全过程，构建服务、执法、管理三位一体的新型行政执法模式。一是坚持事前预防指导，服务走在监管前。严格落实“谁执法谁普法”责任制，畅通政企沟通渠道，强化合规指导服务，多形式开展普法宣传教育，及时解决行政相对人急难愁盼问题，推动企业从“被动合规”向“主动履责”转变，持续提升质量管理水平。二是坚持事中刚柔并济，服务贯穿执法中。推行说理式执法和包容审慎监管，在日常监管、执法检查和案件办理等工作中，主动讲明执法目的、要求、依据、事实、后果和救济渠道等。依法运用药品监管领域“首违不罚”清单，给予轻微违法行为容错空间。严厉打击重点领域违法违规行为，曝光典型违法案件，将重大违法企业纳入“黑名单”，营造健康有序的法治化营商环境。三是坚持事后综合施策，服务延伸整改后。通过“回头访”“回头看”“回头检”等方式，强化对问题产品和企业的整改核查和跟踪问效，规范企业合规生产经营。建立“容错＋信用修复”闭环管理机制，优化修复业务流程，对失信企业提供“一对一”合规指导，鼓励企业主动纠正失信行为，消除不良社会影响。构建内部与外部相结合的双重监督体系，不断强化执法监督效能，推动形成“监管部门主抓、兼职人员配合、协会主动作为、群众积极参与”新局面。下一步，省药监局将科学把握执法尺度、力度和温度，在执法过程中做到惩教结合、宽严相济、过罚相当，统筹推进严格规范公正文明执法与为人民服务深度结合，着力打造更加规范公正的法治环境、公平有序的竞争环境、优化便捷的营商环境。

为加强医疗器械质量监督管理，保障医疗器械产品使用安全有效，江西省药品监督管理局按照2024年度全省医疗器械抽检工作方案，持续对本省医疗器械生产、经营和使用环节实施了监督抽样检验。信息如下：                                                                   江西省药品监督管理局 2025年4月24日

近期，江苏省药品监督管理局在监督检查中发现，徐州市圣普医疗设备技术有限公司：（苏食药监械生产许20010060号）的质量管理体系存在关键缺陷项，不符合《医疗器械生产质量管理规范》相关规定。根据《医疗器械生产监督管理办法》第六十四条第二款，现对以上企业采取暂停生产的风险控制措施。特此公告。江苏省药品监督管理局2025年4月23日

为规范涉企行政执法行为，优化法治化营商环境，省药品监督管理局现就公开征集涉企行政执法问题线索有关事项公告如下。一、征集范围2023年以来，全省各级药品监督管理部门涉企行政执法存在的下列问题线索：（一）乱收费问题。违规设立收费项目，公示项目收费不规范，提高收费标准；变相强制行政相对人接受有偿服务、指定购买；不按要求执行国家和地方已出台的惠企收费政策等情形。（二）乱罚款问题。超出法定权限或范围进行罚款；未规范执行裁量权基准，随意进行大额顶格处罚；重复处罚；罚没收入异常增长；过度罚款，不适用相关法律规定给予减轻处罚、免予处罚，类案不同罚、过罚不相当、畸轻畸重等情形。（三）乱检查问题。实施检查主体不适格；超越法定职责开展检查；行政检查事项未经公布；执法扰企，多头检查、多层检查、重复检查，对同一主体检查明显超过合理频次；随意检查，检查程序不合法，检查“走过场”，运动式检查等情形。（四）乱查封问题。滥用行政强制措施，超权限、超范围、超额度、超时限查封涉案财产等情形。（五）违规异地执法问题。超越法定管辖范围，对非本辖区的行政相对人进行执法活动；利用行政执法手段插手异地的经济纠纷；未履行协作程序或超越协作权限在异地开展执法等情形。（六）趋利性执法问题。下达或变相下达行政罚没款、执法数量考核指标；为增加行政罚没收入脱离实际监管随意设置电子技术监控设备；将行政罚没收入与本单位业务经费、福利待遇挂钩；违规预收、私自截留罚没款，违反“罚缴分离”规定等情形。（七）其他问题。吃拿卡要，收受或索取财物；指定购买商品服务、接受有偿服务；办关系案、人情案、金钱案等以权谋私、权力寻租的问题等情形。二、征集方式通过电话、电子邮箱、来信方式征集，具体联系方式如下：电话：029－62288354　   电子邮箱：syjj－zcfgc＠shaanxi．gov．cn邮寄地址：西安市高新六路56号（陕西省药品监督管理局政策法规处）邮　   编：710065三、征集时间自本公告发布之日起，至2025年7月31日止。电话征集时间为：工作日上午9：00－11：00；下午3：00－5：00。四、相关事项已进入、已经过纪检监察、行政复议、行政诉讼、信访等法定程序办理的问题线索不纳入本次征集范围。陕西省药品监督管理局2025年4月23日

序号行政处罚决定书文号违法企业名称或自然人姓名法定代表人姓名违法企业组织机构代码违法行为类型主要违法事实行政处罚的内容行政处罚的依据履行方式和期限作出处罚决定的行政机关和日期1鄂药监武药处罚〔2025〕5号湖北诺肯药业有限公司夏水舟91420103MA49P3YN16销售劣药当事人销售劣药盐酸雷尼替丁注射液（生产厂家：河南利欣制药股份有限公司，规格：2ml：50mg*10支/盒，批号：Z23121811）的行为，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。没收违法所得。《中华人民共和国行政处罚法》第二十八条第一款及《中华人民共和国药品管理法实施条例》第七十五条的规定。主动履行，当事人收到行政处罚决定书之日起十五日内。湖北省药品监督管理局2025年04月18日

行政相对人名称安徽见琛药业有限公司行政相对人类别法人及非法人组织统一社会信用代码91341600MA2UBDUG55法定代表人刘皊芝行政处罚决定书文号皖药监药处罚﹝2024﹞2-103号处罚类别警告;罚款;没收违法所得处罚决定日期2025-04-23处罚内容1.警告；2.没收在非批准车间生产的黑顺片（批号：241003）数量：55Kg和清半夏（240701）数量：110Kg，给予货值金额壹万壹仟贰佰柒拾伍元整（11275.00元）6.0倍(货值金额不足十万元的，按十万元计算),罚款陆拾万元整（600000.00元），合计陆拾壹万壹仟贰佰柒拾伍元整（611275.00元）。罚款金额（万元）60.000000没收违法所得、没收非法财物的金额（万元）1.127500暂扣或吊销证照名称及编号-违法行为类型《中华人民共和国药品管理法》（2019年修订）第四十三条第一款，《药品生产监督管理办法》第六十八条违法事实1.2024年11月29日，我局组织的检查组对该企业进行常规检查，现场发现位于厂区内的备用库（非认证车间，3号楼）存在问题：厂区南侧厂房是非认证车间。现场地面塑料布上放有两个品种：①黑顺片（批号：241003，包装规格：20Kg/袋）为2024年11月21日重庆古裕经医药有限公司购进100Kg，购进价格55元/Kg,货值金额8820.00元。因为客户要求的规格与公司生产的不相符做换货处理，2024年11月25日重庆古裕经医药有限公司退回，该公司在备用库重新进行包装，并重新打印了标签；货值金额3025.00元；②清半夏（批号：240701，包装规格50Kg/袋）为2024年9月25日销售510Kg,销售价格75.00元/Kg,货值金额38250.00元，洛阳顺势药业2024年10月20日退货产品110kg，因为成品库的改造，影响包装车间，所以临时在备用库房进行处理、包装，货值金额8250.00元，货值金额共11275.00元。③上述两个产品，因为成品库的改造，影响包装车间，临时在备用库房进行处理、包装。备用库房是该公司临时启用的，没有备案。上述生产包装行为属于在未经批准的生产地址进行生产。2.经查，①企业负责人刘皊芝承认本人小学学历，不参与日常管理。查询安徽智慧监管平台，2024年4月29日企业提交企业负责人变更申请，上传了申请书及承诺书，现场询问变更材料为质量负责人上报，企业负责人刘皊芝自述仅上过小学二年级，查看刘皊芝人员档案仅有身份证复印件及健康检查表，无学历证书及培训记录。②2024年12月2日开具《安徽省药品监督管理局场所/设施/财务清单》（文书编号：〔2024〕1129号）的33个品种中的法半夏、姜半夏、清半夏、半夏、天南星、制天南星、草乌、黑顺片、生附片都是公司生产的产品，生产时是大包装，只有大包装记录，也没有打印标签。然后再按客户要求进行分包装，没有分装记录。上述情形不符合《药品生产质量管理规范》“《药品生产质量管理规范》第四条：企业应当严格执行本规范,坚持诚实守信,禁止任何虚假、欺骗行为。第一百五十九条：与本规范有关的每项活动均应当有记录,以保证产品生产、质量控制和质量保证等活动可以追溯。记录应当留有填写数据的足够空格。记录应当及时填写,内容真实,字迹清晰、易读,不易擦除。之规定。处罚依据《中华人民共和国药品管理法》（2019修订）第一百一十五条、《中华人民共和国药品管理法》（2019年修订）第一百二十六条处罚机关安徽省药品监督管理局处罚机关统一社会信用代码11340000MB19570665数据来源单位安徽省药品监督管理局数据来源单位统一社会信用代码11340000MB19570665

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Jian ZhangChief Executive OfficerNoah Medical Corporation2075 Zanker RoadSan Jose,CA95131United Statesjianzhang@noahmed.comIssuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS #702414April 09, 2025Dear Ms. Zhang:During an inspection of your firm located at 2075 Zanker Road, San Jose, CA 95131 on October 28, 2024, through November 26, 2024, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures bronchoscopes and accessories (branded as the Galaxy 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.This 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 Richard W. Reeves, Vice President Quality Assurance and Regulatory Affairs, dated December 18, 2024, and January 21, 2025, concerning our investigators’ observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm1. We address the 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 corrective and preventive action, as required by 21 CFR 820.100(a).Specifically, your firm failed to adequately establish your “Corrective and Preventive Action (CAPA)” procedure (SOP-019 Rev. B, Effective Date: 10/30/2024), as your firm did not adequately conduct and document CAPA investigations. For example, according to your procedure, a Corrective Action/Preventive Action (CAPA) process shall be established to ensure “investigations are conducted to a degree sufficient to determine the root cause.” However, 2 out of 17 CAPA records selected for review by our investigators did not identify the root causes and necessary corrective and preventive actions as required by your CAPA procedure. The following describes the two CAPA records:a. CAPA 24-007 dated 9/11/2024: Your firm failed to conduct adequate investigations as required by your CAPA procedure. For example, your firm failed to explore sufficiently to determine the root cause for “biopsy tools couldn’t pass through bronchoscope’s working channels.” You did not investigate, sufficiently to determine the root cause, the lot-to-lot variation of the distal end measurements of the working channels and how it may impact your root cause analysis.b. CAPA 23-005 dated 4/14/2023: This CAPA record reported two scope pouches leaking due to the(b)(4)poking holes in the pouches during shelf-life/packaging transportation study Protocol “Design Verification Protocol for Bronchoscope Packaging,” (DOC: TP-099 Rev. B), and test report #WP-12154A. During execution of the(b)(4)aging testing of the sterile bronchoscope, a test failure was noted during a gross leak testing of the scope pouches. Your firm did not evaluate how many scope pouches were leaking to identify other potential causes of the failed leak test, such as quality issues with your suppliers. Subsequently, your scope pouches failed leak test during a(b)(4)aging study (test report number #WP-16128A), but your firm did not document the cause of the leak nor reference this failed leak test in CAPA 23-005.We reviewed your responses, and their adequacy cannot be determined at this time. Your responses indicate that your firm initiated CAPA 24-028. You indicate that your firm made immediate corrections to CAPA 24-007; plans to contract with a third-party to retrospectively review all open and closed CAPAs, including the CAPAs cited during the last inspection; revised the CAPA process; and completed relevant training on the revised CAPA procedure including revised work instructions. However, the CAPA activities are still ongoing, and your responses do not clearly specify the target completion date for the overall CAPA 24-028 record.2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).Specifically, your complaint procedure, “Complaint Management,” (SOP-025, Rev. G, Effective Date: 10/28/2024) has not been adequately established as your firm did not adequately conduct and/or document complaint investigations. For example,a. Your procedure indicates complaint investigations are conducted to “determine the cause of any product defects and/or malfunctions, whether product met specifications, or whether product specifications were met, but were inadequate.” Your firm did not follow your procedure as exemplified below:i. Complaint #00003531 described a failure to acquire live video feed upon attaching the scope to the instrument driving mechanism (IDM). Your firm did not adequately investigate the cause(s) of camera image loss.ii. Complaint #00002229 involved a user experiencing scope buckling errors due to severe kink in the distal area and the user had to replace with another scope. However, your firm did not investigate cause(s) for the kinks.iii. Complaint #00003614 described a patient experiencing excessive bleeding during Galaxy-assisted procedure. Complaint record states “scope buckling malfunction was observed.” However, your firm did not identify cause(s) for scope buckling.b. Your procedure states complaint “investigation examples may include, but is not limited to … batch record review to determine if there were nonconformances, material used, or process steps that could have contributed to the complaint.” For complaint #00003610 involving a patient who had pneumothorax while undergoing a Galaxy-assisted biopsy procedure for a 14mm lesion in the left upper lobe, the patient got a chest tube insert and was admitted to the hospital for 3 days. Your firm did not review batch records and other quality data sources for the bronchoscope used in this procedure to investigate and determine whether your device could have contributed to the patient’s injury.c. Your procedure states that “additional information from the complainant may be required to process a complaint” and that “various methods of communication … should be attempted in order to make a good faith effort to contact the complainant.” However, your firm failed to conduct and/or document a good faith effort to obtain additional information to support the complaint investigations. For example:i. Complaint #00003544 has a death reported due to excess bleeding when a patient was undergoing a Galaxy-assisted bronchoscopy procedure. According to your firm’s representative and associated complaint record, the physician stated that “the patient had possibly forgotten to stop taking blood thinners” and patient possibly was “puncture[d] by biopsy forceps.” Your firm’s Clinical Engineer reviewed the video of the procedure and said she could not see the forceps puncturing the blood vessel because there was too much blood blocking the camera view. Your firm did not make any attempt(s) to verify the causes further.ii. Complaint #00003337 involves a procedure that was aborted due to broken joysticks on two different controllers resulting in the scope drifting significantly into the patient’s right upper lobe of the lung. There was no documented information on when the patient was rescheduled for another procedure nor if the patient experienced any adverse event(s) after aborted procedures.We reviewed your responses, and their adequacy cannot be determined at this time. Your responses indicate that your firm initiated CAPA 24-025, CAPA 24-026, and CAPA 24-015. Your responses indicate that your firm has made some progress including completion of the root cause investigation for CAPA 24-015. However, the CAPA activities are still ongoing for all three CAPA records, and your responses do not clearly specify the target completion dates for each overall CAPA record.3. Failure to establish and maintain procedures for design control, as required by 21 CFR 820.30.Specifically, your design control procedure, “Design Controls” (SOP-002, Rev. G, Effective Date: 10/21/2024), has not been adequately established.2For example, your design control procedure states that “Design verification and validation shall be conducted in accordance with SOP-033…to ensure design outputs meet the design input requirements and the product meets its intended use.” However, your firm failed to establish the procedure as follows:a. Your firm failed to adequately conduct design validation for the(b)(4)biopsy tools, such as(b)(4), listed on page 23 of IFU Rev J, Effective Date: 09/25/2024. During design validation, your firm only performed design validation for the(b)(4)and used the(b)(4)as the worst-case tool for biopsy tool passage. Furthermore, your firm only tested biopsy tool passage in a(b)(4)configuration of the bronchoscope instead of(b)(4)configuration to account for bending of the bronchoscope. Your firm initiated CAPA 24-007 after the complaint trend associated with biopsy tools not passing through working channel “exceeded the required action threshold.”b. Your procedure failed to define the requirements to test sterility as part of the shelf-life validations. Your bronchoscopes are sold as sterile with an expiration date of two years, but your firm did not test product sterility as part of the shelf-life validations in the following protocols:i. Protocol #TP-008, Revision E, describing the(b)(4)aging study, titled: “Galaxy Bronchoscope Verification Test Plan” and Summary Report #TR-087, Revision C.ii. Protocol #TP-008, Revision E, describing the(b)(4)aging study, titled: “Galaxy Bronchoscope Verification Test Plan,” and Summary Report WP-16128A, Date Reviewed 05/08/2024.iii. Protocol #TP-099, Revision B, relating to the(b)(4)aging study, titled: “Design Verification Protocol for Bronchoscope Packaging (includes(b)(4)and(b)(4)configurations)” and Summary Report #TR-378, Revision A.We reviewed your responses, and their adequacy cannot be determined at this time. Your responses indicate that your firm initiated CAPA 24-016 and CAPA 24-018. You indicate “as part of the Corrective Action, all instances of Design Verification and Validation of Requirements are being reviewed and where assumptions were made, these are being tested against documented evidence” (your firm’s response dated January 21, 2025). The CAPA activities are still ongoing for all three CAPA records, and your responses do not clearly specify the target completion dates for each overall CAPA record.4. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).Specifically, your procedure, “Nonconforming Material,” (SOP-018 Rev. G, Effective Date: 09/24/2024,), has not been adequately implemented. Your firm failed to conduct investigations to identify the root cause(s) as required by your nonconforming material procedure. For example:a. NCR 0367 (Dated 04/11/2024) involves(b)(4)bronchoscopes failing leak test due to(b)(4)in the working channels (part(b)(4)). However, your firm did not conduct investigation to identify the root cause(s) of the(b)(4)nor implement a SCAR with your supplier.b. NCR 0605 (Dated 09/20/2024) involves(b)(4)bronchoscopes failing leak tests. One failure was due to the working channel not adequately bonded to the(b)(4), and the other(b)(4)failures were due to(b)(4). However, your firm did not conduct investigation to identify the root cause(s) for the inadequate bonding nor the exposed(b)(4).c. NCR 0071 (Dated 07/27/2023) involves(b)(4)working channels found to have kinks. However, your firm failed to investigate to identify the root cause(s) for the kinks nor implement a SCAR with your supplier.We reviewed your responses, and their adequacy cannot be determined at this time. Your responses indicate that your firm initiated CAPA 24-021. Your responses indicate that your firm plans to update your procedures, conduct training once the revised procedures are complete, and address immediate issues including review of all NCRs to date (starting from May 2023, approximately(b)(4)NCRs) and identify those which require investigation or revisions. Also, you indicate that there was immediate containment for the NCRs cited during the recent inspection and your firm issued SCAR number 24-010 to your supplier to determine the root cause of working channel defects. However, the CAPA activities are still ongoing, and your responses do not clearly specify the target completion date for the overall CAPA record.5. Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2). Rework and reevaluation activities, including a determination of any adverse effect from the rework upon the product, shall be documented in the device history record (DHR), as required by 21 CFR 820.90(b)(2).Specifically, your procedure, “Rework and Deviation,” (SOP-020 Rev. B, Effective Date: 11/28/2022), has not been adequately established. For example, your Rework and Deviation procedure failed to include the requirement for determining whether there has been any adverse effect from rework upon the product when documenting rework and reevaluation activities. For example, the DHR for “Galaxy, Cart,(b)(4)” CRB-1516 (part number(b)(4)), relates to nonconformance #108, which described a nonconformance with an instrument driving mechanism ((b)(4)) on the Galaxy System robot. This nonconformance resulted in frozen bronchoscope camera images. The(b)(4)were replaced. However, your firm did not document a determination of whether there has been any adverse effect from reworking the(b)(4)upon the “Galaxy, Cart,(b)(4)” CRB-1516.We reviewed your responses, and their adequacy cannot be determined at this time. Your responses indicate that your firm initiated CAPA 24-022. Your responses indicate that you have revised your Rework and Deviation procedure and plan to conduct “a retrospective review of NCRs, rework, complaints and field repairs for all shipped systems to date as well as those in inventory to determine if any adverse effects are evident, and plan to implement corrections” (your response dated January 21, 2025). However, the CAPA activities are still ongoing, and your responses do not clearly specify the target completion date for the overall CAPA record.Our inspection also revealed that your firm’s Galaxy 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 devices 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 submit a report to FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).For example, the information included for Complaint #00003935 and #00003614 reasonably suggests that during a procedure where your firm’s Galaxy System was used, the patients sustained injuries resulting in bleeding that were treated with irrigation and suction (Complaint #00003935) and Levophed administration (Complaint #00003614). We determined that these interventions were necessitated to prevent permanent impairment of a body function or permanent damage to a body structure (21 CFR 803.3(w)(3)). Your firm became aware of Complaint #00003935 on August 21, 2024, and FDA has not yet received an MDR for the corresponding MDR reportable event.Your firm became aware of Complaint #00003614 on July 24, 2024. Although the corresponding MDR #3021325287-2024-00024 was received by FDA on January 13, 2025, it was received beyond the 30-calendar-day timeframe.The adequacy of your firm’s responses cannot be determined at this time. The responses indicate that your firm initiated a root cause investigation, plans to streamline its MDR reporting process, and is conducting a retrospective review of complaints for reportability. However, in the responses, your firm did not include documentation or evidence to demonstrate that the systemic corrective actions have been fully implemented, as these efforts are still ongoing.Our inspection also revealed that your firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. For example, during the inspection, the document titled “Medical Device Reporting,” Doc# SOP-026, Rev. C, dated 10/28/2024, was presented as your firm’s written MDR procedure. After reviewing the MDR procedure, the following deficiencies were noted:The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example, the procedure omits the definitions of the terms “caused or contributed” from 21 CFR 803.3 and “reasonably suggests” found in 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).Your firm’s responses did not address the noted procedural deficiencies, as these were not included in the FDA Form 483.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 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 Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent to: cdrhenforcement@fda.hhs.gov. Please include in the subject line, CMS case #702414 when replying. If you have any questions about the contents of this letter, please contact: Linda Linh Adams, Compliance Officer, at lindalinh.adams@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 yours,/S/Matthew G. HillebrennerDeputy DirectorOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCc: Sam Mostafavi, Regulatory Advisor/ Management Representative, at sammostafavi@noahmed.com_______________________1FDA also received a response dated February 18, 2025. This letter does not address that response given timing considerations. That response will be considered along with any response to this letter.2Under 21 CFR 820.3(k), “establish” means define, document (in writing or electronically), and implement.