工艺验证、文件管理以及设备维保不符合cGMP要求，FDA发出警告信。
WARNING LETTER
Global Medical Production Co Ltd
MARCS-CMS 620544 — NOVEMBER 16, 2021
November 16, 2021
Dear Mr. Dai:
During an inspection of your firm located in Jiaxing, China on July 15, 2021 through July 30, 2021, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Sterile and Non-Sterile Electrosurgical Scissors, Sterile Electrosurgical Graspers, and Sterile Veress Pneumoperitoneum Needles. 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 function of the body.
在2021年7月15日至2021年7月30日对位于中国嘉兴的一家公司进行检查期间，美国食品和药物管理局(FDA)的一名调查人员确定，贵公司生产无菌和非无菌电手术剪刀、无菌电手术钳和无菌无气腹针。根据《联邦食品、药品和化妆品法》(《法案》)第201(h)条，21 U.S.C.§321(h)，这些产品是医疗器械，因为它们用于疾病或其他状况的诊断，或用于治疗、缓解、治疗或预防疾病，或用于影响身体结构或功能。
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 two responses from you, dated August 19, 2021 and September 20, 2021, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which 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 following:
此次检查显示，这些设备在《法案》第501(h)条，21 U.S.C.§351(h)的含义中存在掺假，因为它们的制造、包装、储存或安装中使用的方法或设施或控制不符合《联邦法规法典》(CFR)第820部分第21篇质量体系法规的当前良好生产规范要求。我们收到了来自企业的两份回复，日期分别是2021年8月19日和2021年9月20日，关于我们在发给贵公司的FDA 483 (FDA 483)表格《检查观察清单》上记录的调查观察。我们在下面针对每一项违规行为作出回应。这些违反行为包括但不限于下列行为:
1. Failure to establish and maintain adequate procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
1. 未能按照21 CFR 820.30(a)的要求，建立和维持足够的程序来控制装置的设计，以确保满足规定的设计要求。
For example, your firm has not established Design Control procedures related to its private label manufactured medical devices intended for the US market to include Class II Sterile and Non-Sterile Electrosurgical Scissors, Class II Sterile Electrosurgical Graspers, and Class II Sterile Veress Pneumoperitoneum Needles. Additionally, your firm was unable to provide documentation and/or evidence of conducting Design and Development activities for these medical devices. This is a repeat violation from the previous inspection in April 2015.
例如，贵公司没有建立针对其用于美国市场的自有标签医疗器械的设计控制程序，包括第II类无菌和非无菌电手术剪刀、第II类无菌电手术钳和第II类无菌无气腹针。此外，贵公司无法提供为这些医疗设备进行设计和开发活动的文件和/或证据。这是2015年4月检查时的重复违规。
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that it would conduct training on 21 CFR 820.30 Design Control and Design Control Procedure, and retrospectively establish Design History Files for all products. The response also stated that your firm would provide training records, design history files for all of its products, effectiveness check reports, recommendations for additional actions or closure if applicable, and training records related to these corrective actions. However, the response did not indicate that there would be any assessment to determine the impact of the lack of design control activities for devices that were already distributed. Additionally, your firm has not provided documentation or evidence of implementation of a corrective action plan. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.
我们审阅了贵公司的回复，认为它是不充分的。贵公司的回复说，企业将对21 CFR 820.30设计控制和设计控制程序进行培训，并对所有产品进行回顾性建立设计历史文件。回复中还指出，贵公司将提供培训记录、所有产品的设计历史文件、有效性检查报告、附加措施或关闭措施(如适用)的建议，以及与这些纠正措施相关的培训记录。但是，答复没有表明将进行任何评估，以确定对已经分发的设备缺乏设计控制活动的影响。此外，贵公司没有提供实施纠正行动计划的文件或证据。没有这样的文件，FDA不能对充分性进行评估。请提供企业在答复中概述的纠正措施的证据。需要这些信息来评估这些纠正措施是否已经完成。
2. Failure to establish and maintain procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90(a).
2. 未能建立和维持程序来控制不符合21 CFR 820.90(a)规定要求的产品。
For example, your firm’s Nonconforming Product Control Procedure, Doc No. 28301, Ver. 2 and dated February 01, 2018; has no requirement for: the evaluation and disposition of nonconforming products, which should include procedures for determination of the need for an investigation and notification of the person or organizations responsible for the nonconformance. Additionally, during the inspection of your firm’s list of 2019-2021 nonconforming products, there was no documentation or evidence that your firm had conducted a determination of the need for an investigation or notification of the persons and organizations responsible for the nonconformance.
例如，贵公司2018年2月1日的《不合格品控制程序》(Doc No. 28301, Ver. 2);对不合格品的评价和处理没有要求，其中应包括确定是否需要调查和通知不合格品责任人或组织的程序。此外，在检查贵公司2019-2021年不合格品清单期间，没有文件或证据表明贵公司已经确定需要对不合格品的责任人和组织进行调查或通知。
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that it would revise the Nonconforming Product Procedure Document Number 28301 to add missing information for the evaluation and disposition of nonconforming products, which should include a determination of the need for an investigation and notification of the person or organization responsible for the nonconformance. Your firm also stated that it would retrospectively review the history of Nonconforming product and determine the need for an investigation as well as notification of the persons and organizations responsible for the nonconformance and disposition of the nonconforming product. Additionally, effectiveness checks would be initiated after all corrective and preventive actions were taken. However, the response did not indicate that there would be an assessment to determine if the lack of disposition requirements led to a release of nonconforming product and how that risk will be addressed. Additionally, your firm has not provided documentation or evidence of implementation of the corrective actions as they are still ongoing. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.
我们审阅了贵公司的回复，认为它是不充分的。贵公司的回复称，将修订不合格品程序文件编号28301，增加不合格品评估和处理的缺失信息，其中应包括确定是否需要进行调查，并通知不合格品责任人或组织。贵公司还表示，将对不合格品的历史进行回顾性审查，并决定是否需要进行调查，通知不合格品的责任人和组织，并对不合格品进行处理。此外，在采取了所有纠正和预防行动之后，将开始进行有效性检查。但是，答复没有表明将进行评估，以确定缺乏处理要求是否会导致不合格产品的放行，以及该风险将如何处理。此外，贵公司没有提供实施纠正措施的文件或证据，因为纠正措施仍在进行中。没有这样的文件，FDA不能对充分性进行评估。请提供企业在答复中概述的纠正措施的证据。需要这些信息来评估这些纠正措施是否已经完成。
3. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a).
3.未能充分确保当工艺结果无法通过后续检查和试验得到充分验证时，应按照21 CFR 820.75（a）的要求，以高度保证的方式对工艺进行验证，并根据既定程序进行批准。。
For example, your firm was not able to provide Performance Qualification (PQ) objective data and evidence or results of the PQ activities. Your firm stated that it does not have the results of the PQ conducted for its heat-sealing process validation activities, which is used in manufacturing processes of medical devices exported and intended for the US market. This is a repeat violation from the previous inspection in April 2015.
例如，贵公司无法提供PQ活动的客观数据和证据或结果。贵公司声明没有对其热封工艺验证活动进行PQ的结果，热封工艺用于出口到美国市场的医疗器械的制造工艺。这是2015年4月检查时的重复违规。
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that it would execute a new Performance Qualification and would also assess all other processes and Performance Qualifications for objective data and results. A new Performance Qualification would be executed where data or results were not found. Your firm stated it would provide the agency with PQ data, its PQ summary Report, effectiveness check reports, recommendations for additional actions or closure if applicable, and training records. However, the response did not indicate that there would be any corrective actions to ensure that the firm maintains such records in the future. Additionally, your firm has not provided documentation or evidence of implementation of the corrective actions as they are still ongoing. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. We request this information to assess whether these correction actions were completed.
我们审阅了贵公司的回复，认为它是不充分的。贵公司的回复说，它将执行一个新的绩效考核，也将评估所有其他过程和绩效考核的客观数据和结果。在没有发现数据或结果的地方，将执行一个新的性能确认。贵公司声明将向FDA提供PQ数据、PQ总结报告、有效性检查报告、额外行动或关闭建议(如适用)以及培训记录。然而，该答复并未表明将采取任何纠正措施，以确保该公司今后保持此类记录。此外，贵公司没有提供实施纠正措施的文件或证据，因为纠正措施仍在进行中。没有这样的文件，FDA不能对充分性进行评估。请提供企业在答复中概述的纠正措施的证据。我们要求这些信息来评估这些纠正行动是否已经完成。
4. Failure to conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules, as required by 21 CFR 820.70(g)(1).
4. 未能按照21 CFR 820.70(g)(1)的要求，按照既定程序进行定期检查，以确保遵守适用的设备维护时间表。
For example, your firm has not established a maintenance schedule for your Production Controlled Room Air Handling HEPA Filters and Water Purifier, Equipment No. 08, used in the ultrasonic cleaning of components of your firm’s private label manufactured medical devices intended for the US market, to include Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Scissors, Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Graspers, and Class II Sterile Veress Pneumoperitoneum Needles.
例如，贵公司没有为生产控制室空气处理HEPA过滤器和净水器(设备08号)建立维护计划，该设备用于超声波清洗贵公司专用标签制造的用于美国市场的医疗器械部件，包括第II类一次性无菌和非无菌可重复使用电手术刀，第II类一次性无菌和非无菌可重复使用电手术刀，和II类无菌气腹针。
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that it would establish a maintenance schedule for the Production Controlled Room Air Handling HEPA Filters and Water Purifier Equipment No. 08. Your firm stated that it would provide training for new procedure and provide the agency with records of the retrospective schedule, maintenance schedules, effectiveness check reports and a recommendation for additional actions or closure. However, the response did not indicate that there would be an assessment to determine the impact from the lack of maintenance schedule on previously released product. Additionally, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. We request this information to assess whether these correction actions were completed.
我们审阅了贵公司的回复，认为它是不充分的。贵公司的回复说，它将为生产控制室空气处理高效空气过滤器和净水器设备08号建立维护时间表。贵公司声明将为新程序提供培训，并向机构提供追溯时间表、维护时间表、有效性检查报告的记录，以及对额外行动或关闭的建议。然而，答复没有表明将进行评估，以确定缺乏维护计划对之前发布的产品的影响。此外，贵公司没有提供实施纠正措施的文件或证据。没有这样的文件，FDA不能对充分性进行评估。请提供企业在答复中概述的纠正措施的证据。我们要求这些信息来评估这些纠正行动是否已经完成。
5. Failure to identify by suitable means the acceptance status of product, to indicate the conformance or nonconformance of product with acceptance criteria, as required by 21 CFR 820.86.
5. 未能按照21 CFR 820.86的要求，以适当的方式确定产品的验收状态，表明产品符合或不符合验收标准。
For example, your firm had product in the warehouse that was labeled as “sterile” and was intended for the U.S. market. However, the product should have been identified as "Non-Sterile” to indicate its non-processed and non-sterile status to ensure only medical devices that have undergone the sterilization process are accepted and distributed to the US market. Your firm stated that it has no process or requirement to ensure “Non-Sterile” product is conspicuously labeled to indicate its non-processed, non-sterile status from sterile product. Your firm does not follow its Nonconforming Product Control Procedure, Doc No. 28301, Ver. 2 and dated February 01, 2018. Medical device components and finished medical devices were not properly identified to ensure that only product which has passed the required acceptance activities are distributed or used.
例如，贵公司的仓库中有标签为“无菌”的产品，是针对美国市场的。然而，该产品应该被标识为“非无菌”，以表明其未加工和非无菌状态，以确保只有经过灭菌过程的医疗器械才被接受和分销到美国市场。贵公司声明，没有程序或要求确保“非无菌”产品的显著标记，以表明其从无菌产品的未加工非无菌状态。贵公司没有遵守其2018年2月1日颁布的第28301号文件第2版《不合格品控制程序》。没有正确标识医疗器械部件和成品医疗器械，以确保只有通过所需验收活动的产品才能分发或使用。
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s response stated that your firm would revise Document 27502, Product Identification and Traceability to add method for identifying the status of product. Your firm also plans to establish a new procedure to address placing the sterile indicator label on the product package to identify product before and after the process of sterilization by December 15, 2021. Your firm will establish a new procedure for physically separating product and identifying each location with product status. Document 28301, section 6.3.2.1 and 6.3.2.2, will be revised to remove sections for green and red labels and replace with a label that has a section to indicate accept or reject status. The Identification Procedure will be revised to include physical storage area status.
我们审阅了贵公司的回复，认为它是不充分的。贵公司的回复说，贵公司将修改文件27502，产品标识和可追溯性，增加识别产品状态的方法。贵公司还计划在2021年12月15日前建立新的程序，在产品包装上放置无菌指示标签，以识别灭菌前后的产品。贵公司将建立一个新的程序，将产品进行物理分离，并用产品状态标识每个位置。28301号文件第6.3.2.1和6.3.2.2节将被修订，删除绿色和红色标签的部分，取而代之的是一个有部分表示接受或拒绝状态的标签。识别程序将被修订，以包括物理存储区域的状态。
A new procedure will be established to identify scrap product with "not for human use label." Your firm will identify storage areas in the facility with proper identification and segregate manufacturing and storage areas to prevent possible mix-ups. Products will be quarantined in the unmarked storage room and assign a Non-Conformance Number to the product, disposition of the product, and identity of the product. Additionally, upon completion of all corrective and preventive actions, your firm will conduct an effectiveness check. Based on results of the effectiveness check, GMP may recommend additional actions or closure of this observation. However, the response did not indicate that there would be an assessment to determine if the lack of adequate identification led to the release of unsterilized product. Additionally, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.
将建立一套新的程序，以识别贴有“不供人使用标签”的报废产品。贵公司将用适当的标识识别设备中的存储区域，并将生产区域和存储区域隔离，以防止可能的混淆。产品将被隔离在无标记的储藏室中，并为产品分配不合格编号、产品的处置和产品的标识。此外，在完成所有纠正和预防措施后，贵公司将进行有效性检查。根据有效性检查的结果，GMP可以建议采取其他措施或终止观察。但是，答复没有表明将进行评估，以确定缺乏充分的标识是否会导致未灭菌产品的放行。此外，贵公司没有提供实施纠正措施的文件或证据。没有这样的文件，FDA不能对充分性进行评估。请提供企业在答复中概述的纠正措施的证据。需要这些信息来评估这些纠正措施是否已经完成。
6. 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).
6. 未能按照21 CFR 820.198(a)的要求，建立和维持由正式指定的部门接收、审查和评估投诉的程序。
For example, your firm’s Customer Complaint Control Procedure, Doc No. 28502, Ver. 3, and dated February 01, 2018, has no requirement to ensure your firm is receiving complaints from its sole distributor that is marketing and selling its private label manufactured medical devices in the US market. Additionally, your firm has no documented agreement with its sole US private label distributor requiring them provide your firm with complaints to ensure that it reviews and evaluates all complaints in a uniform and timely manner to determine whether an investigation is necessary and are evaluated to determine whether the complaint represents an event, which is required to be reported to the USFDA under 21 CFR Part 803 - Medical Device Reporting (MDR).
例如，日期为2018年2月1日的贵公司《客户投诉控制程序》(Doc No. 28502, Ver. 3)没有要求确保贵公司收到来自其在美国市场营销和销售自有标签医疗器械的独家经销商的投诉。此外，贵公司与其唯一的美国私人标签分销商没有书面协议，要求他们向贵公司提供投诉，以确保贵公司以统一和及时的方式审查和评估所有投诉，以确定是否有必要进行调查，并评估以确定投诉是否代表事件，根据21 CFR Part 803 -医疗器械报告(MDR)要求向美国FDA报告。
We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that it executed a Quality Agreement with its US Distributor that requires the distributor to provide your firm with complaints and provided the agency with a copy of this agreement. Your firm’s response stated that it would revise its Customer Complaint Procedure and retrospectively establish a Customer Complaint Log to record complaint activities. Additionally, the response stated that it would review and evaluate all complaints in a uniform and timely manner to determine whether an investigation is necessary. The response also stated that it would provide the agency with its revised procedure, customer complaint logs, effectiveness check reports, recommendations for additional actions or closure if applicable, and training records related to these corrective actions. However, the response did not indicate that there would be a retrospective assessment to determine if the complaints previously received by the initial importer present quality problems that were previously unknown. Additionally, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.
我们审阅了贵公司的回复，认为它是不充分的。贵公司声明其与美国经销商签订了质量协议，要求经销商向贵公司提供投诉，并向代理机构提供了该协议的副本。贵公司在答复中表示，将修订其《客户投诉程序》，并追溯建立《客户投诉日志》以记录投诉活动。此外，答复说，它将以统一和及时的方式审查和评估所有投诉，以确定是否有必要进行调查。答复还指出，它将向该机构提供修订后的程序、客户投诉日志、有效性检查报告、附加措施或关闭措施(如适用)的建议，以及与这些纠正措施有关的培训记录。但是，答复没有表明将进行回顾性评估，以确定最初进口商以前收到的投诉是否存在以前不知道的质量问题。此外，贵公司没有提供实施纠正措施的文件或证据。没有这样的文件，FDA不能对充分性进行评估。请提供企业在答复中概述的纠正措施的证据。需要这些信息来评估这些纠正措施是否已经完成。
7. Failure to maintain device master records as required by 820.181.
7. 未能按820.181要求维护设备主记录。
For example, your firm has not maintained Device Master Records related to your firm's private label manufactured medical devices for the US market to include, Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Scissors, Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Graspers and Class II Sterile Veress Pneumoperitoneum Needles.
例如，贵公司没有维护与贵公司为美国市场生产的自有标签医疗器械相关的设备主记录，包括:第II类一次性无菌和非无菌可重复使用电手术剪刀、第II类一次性无菌和非无菌可重复使用电手术钳和第II类无菌无气腹针。
The adequacy of your firm’s response cannot be determined at this time. Your firm stated it would conduct training to 21 CFR 820.181 its Quality Manual Procedure Document Number 24101, and retrospectively establish a Device Master Records for all products. The response also stated that it would provide Device Master Records for all products, effectiveness check reports, recommendations for additional actions or closure if applicable, and training records related to these corrective actions. However, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.
目前还无法确定贵公司的答复是否充分。贵公司声明将对21 CFR 820.181及其质量手册程序文件编号24101进行培训，并对所有产品回顾性建立设备主记录。该回复还表示，它将提供所有产品的设备主记录、有效性检查报告、附加措施或关闭建议(如果适用)以及与这些纠正措施相关的培训记录。但是，贵公司没有提供实施纠正措施的文件或证据。没有这样的文件，FDA不能对充分性进行评估。请提供企业在答复中概述的纠正措施的证据。需要这些信息来评估这些纠正措施是否已经完成。
8. Failure to maintain device history records as required by 820.184.
8. 未能按照820.184的要求维护设备历史记录。
For example, your firm was not able to provide device history records for private label manufactured medical devices intended and exported to the US market, to include Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Scissors, Class II Sterile Disposable and Non-Sterile Reusable Electrosurgical Graspers and Class II Sterile Veress Pneumoperitoneum Needles.
例如，贵公司无法提供拟出口到美国市场的自有标签生产医疗器械的设备历史记录，包括第II类一次性无菌和非无菌可重复使用电手术剪刀、第II类一次性无菌和非无菌可重复使用电手术钳和第II类无菌无气腹针。
The adequacy of your firm’s response cannot be determined at this time. Your firm’s response stated that it had a device history record for all of its products but that it had not been translated during the inspection. Your firm stated that it would provide a device history records for each product that it would provide recommendations for additional actions. However, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. This information is needed to assess whether these correction actions were completed.
目前还无法确定贵公司的答复是否充分。贵公司的回复说，他们有所有产品的设备历史记录，但在检查期间没有翻译。贵公司声明将为每一种产品提供设备历史记录，并将为附加措施提供建议。但是，贵公司没有提供实施纠正措施的文件或证据。没有这样的文件，FDA不能对充分性进行评估。请提供企业在答复中概述的纠正措施的证据。需要这些信息来评估这些纠正措施是否已经完成。
Our inspection also revealed that your firm’s 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:
我们的检查还发现，贵公司的器械根据《法案》第502(t)(2)条、21 U.S.C.§352(t)(2)条被错误标识，因为贵公司未能或拒绝提供《法案》第519条、21 U.S.C.§360i和21 CFR Part 803 -医疗器械报告要求提供的有关器械的材料或信息。重大违反行为包括但不限于下列情况:
Failure to develop, maintain and implement written a Medical Device Reporting (MDR) procedure, as required by 21 CFR 803.17. For example, during the inspection, your firm acknowledged that it does not have an MDR procedure. This is a repeat violation from the previous inspection in April 2015.
未能按照21 CFR 803.17的要求，制定、维护和实施书面的医疗器械报告(MDR)程序。例如，在检查期间，贵公司承认没有MDR程序。这是2015年4月检查时的重复违规。
The adequacy of your firm’s response cannot be determined at this time. The response noted the following corrective actions: Implement a Medical Device Procedure compliant with 21 CFR 803.17 by September 30, 2021, perform a retrospectively review of all complaints from 2018 to present to evaluate for MDR reportability and submit all the identified MDRs by December 1, 2021 and Perform effectiveness check and report to the FDA within 90 days of completing all corrective and preventative actions. However, your firm has not provided documentation or evidence of implementation of the corrective actions. The FDA cannot make an assessment with respect to adequacy without such documentation. Please provide evidence of the corrective actions that you outlined in your responses. We request this information to assess whether these correction actions were completed.
目前还无法确定贵公司的答复是否充分。该回复指出了以下纠正措施:在2021年9月30日前实施符合21 CFR 803.17的《医疗器械程序》，对2018年至今的所有投诉进行回顾性审查，评估MDR的可报告性，并在2021年12月1日前提交所有确定的MDR，并在完成所有纠正和预防措施后90天内进行有效性检查并向FDA报告。但是，贵公司没有提供实施纠正措施的文件或证据。没有这样的文件，FDA不能对充分性进行评估。请提供企业在答复中概述的纠正措施的证据。我们要求这些信息来评估这些纠正行动是否已经完成。
Given the serious nature of the violations of the Act, Sterile and Non-Sterile Electrosurgical Scissors, Sterile Electrosurgical Graspers, and Sterile Veress Pneumoperitoneum Needles manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are addressed. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and address the violation(s) described in this letter. We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
鉴于违反本法案的严重性质，根据本法案第801(a)条，21 U.S.C.§381(a)条，贵公司生产的无菌和非无菌电手术剪刀、无菌电手术钳和无菌气腹针被拒绝入境，因为它们似乎是掺假的。因此，FDA正在采取措施拒绝这些设备进入美国，被称为“未经检查的扣押”，直到这些违规行为得到解决。为了解除设备的滞留，贵公司应提供一份如下所述的警告信的书面回复，并解决本警告信中所述的违规行为。我们将通知贵公司回应的充分性，以及重新检查贵公司设施的必要性，以验证已经采取了适当的纠正和/或纠正措施。
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.
在考虑授予联邦合同时，其他联邦机构可能会考虑您是否遵守FD&C法案及其实施条例。此外，如果FDA确定企业存在与III类器械上市前批准申请合理相关的质量体系法规违反，在违规问题得到解决之前，此类器械将不会获得批准。
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, including 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. Please provide a translation of documentation not in English to facilitate our review. 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.
请在收到本函之日起15个工作日内，以书面形式将贵公司为解决上述违规行为所采取的具体措施通知本办公室，包括解释贵公司计划如何防止此类违规行为或类似违规行为再次发生。包括贵公司已经采取的纠正和/或纠正措施(必须针对系统性问题)的文件。如果贵公司计划的纠正和/或纠正措施将随着时间的推移而发生，请提供实施这些活动的时间表。如果纠正和/或纠正措施不能在15个工作日内完成，说明延迟的原因和完成这些活动的时间。请提供非英文文件的翻译，以方便我们的审查。如果您认为企业的产品没有违反FD&C法案，请将您的推理和任何支持信息作为您答复的一部分，以供我们考虑。
Your firm’s response should be sent by email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 620544 when replying. If you have any questions about the contents of this letter, please contact: Long Chen at (301) 796-6389.
贵公司的回复应通过电子邮件发送至CDRHWarningLetterResponses@fda.hhs.gov，或通过邮件发送至食品和药物管理局，设备和放射卫生中心，监管项目办公室，监管项目司2:建立支持，监管检查和审计团队，White Oak Building 66, 10903 New Hampshire Ave.，马里兰州银泉20993。回复时参考CMS案例# 620544。如对本信内容有任何疑问，请致电(301)796-6389与陈龙联系。
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.
最后，企业应该知道，这封信并不是要列出贵公司所有的违规行为。确保遵守FDA管理的适用法律法规是贵公司的责任。在本函和检查结束时发布的FDA 483检查意见中指出的具体违规行为可能是贵公司生产和质量管理体系存在严重问题的征兆。贵公司应调查并确定任何违规行为的原因，并立即采取行动解决任何违规行为，使产品符合规定。
Sincerely yours,
/S/
Binita S. Ashar, MD, MBA, FACS
Director
OHT 4: Office of Office of Surgery and
Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological
Health
CC:
Mike Athey
2526 Old Lake Mary Road
Sanford, FL 32773
