FDA验厂常见问题_V2

FDA验厂常见问题注意：递交给FDA的审核文件必须翻译成英文。Subpart B-Quality System Requirements质量体系要求Sec. 820.20 Management responsibility. 管理职责1. 管理职能机构没有对供应商进行定期评审以保证质量体系达到要求问题来源：Merits Health Products Co., Ltd.Notably,the quality system certification maintained for (b)(4) According to your firms management,suppliers are to be reviewed every six months.However, your firms management was unable to provide documentation that these reviews were conductde when asked by the investigator.2. 管理评审和质量体系程序没有形成文件（问题来源：Merits Health Products Co., Ltd.的第5点）Subpart C-Design Controls 设计控制Sec. 820.30 Design controls. 设计控制1. 厂家没有建立并保持有关设计和开发行为的计划（问题来源：Merits Health Products Co., Ltd.的第6点）2. 厂家没有充分建立并保持各种类型器械的DHF（设计历史主文档，DHF应包含或参照必要的原始记录）问题来源：Merits Health Products Co., Ltd.We reviewed your firms response and conclude that it is not adequate. While your firm provided its Design and Development Control Procedure, Document# NLR-QP-36, your firm did not provide a systemic corrective action that would assess the design activities for all product lines. Also, your firm did not provide evidence of implementation of the procedure or training of employees on the procedure.问题来源：Foshan R. Poon Medical Products Co., Ltd.3. 厂家没有建立和维护设计验证程序问题来源： Vega Technologies, Inc. 问题来源：EMG Manufacturing Co., Ltd问题来源：Heartway Medical Products Co., Ltd4. 厂家没有建立并保持设计确认的程序（设计确认包括软件确认及适当时候的风险分析），没有遵守风险分析程序来执行分析验证。问题来源： Vega Technologies, Inc. 5. 设计验收标准没有在设计验证活动之前被建立问题来源： Vega Technologies, Inc. 6. 厂家在设计验证中无法确认设计输出符合设计输入要求问题来源： Vega Technologies, Inc. 7. 厂家没有对校正修订过的验证程序文件问题来源： Vega Technologies, Inc.8. 产品设计记录没有明确的设计验证记录，没有注明验证是基于实际使用环境还是模拟使用环境，也没明确设计验证的方式方法。问题来源：Heartway Medical Products Co., Ltd Heartway Medical Products Co., Ltd的第5点9. 厂家没有定义具体功能的明细或包含测试结果的临界点标准，无法保证设计输入与设计输出的一致性。问题来源：Heartway Medical Products Co., Ltd的第5点Subpart D Document Controls 文件控制Sec. 820.40 Document controls. 文件控制1. 当研发新工艺或变更工艺的时候，厂家在审核发行相关的控制文件之前，没有做充分的验证及书面记录。问题来源：Merits Health Products Co., Ltd. 2. 厂家没有建立和维护文件控制程序问题来源：Merits Health Products Co., Ltd.Subpart E-Purchasing Controls 采购控制Sec. 820.50 Purchasing controls. 采购控制1. 厂家没有建立并保持确保所有购买的或收到的产品和服务符合指定要求的程序。5.Failure to adequately define the type and extent of control to be excrecised over the product,services,supplies,contractor,and consulants,as required by 21CFR 820.50(a)(2). For example, your firms (b)(4) However, there is no documentation that these certificates are reviewed on a regular basis.2. 厂家没有对产品,服务,供应商,承包商和咨询机构的评价结果进行定期更新、记录。问题来源：Merits Health Products Co., Ltd.Subpart F-Identification and Traceability标识和可追溯性 820.65 - Traceability. 可追溯性We reviewed your firms response and conclude that it is not adequate. Your firm has stated that all issues with complaint handling should be mitigated by the implementation of the revised Customer Complaint Handling Procedures, to include the delegation of the task to record external feedback to the Sales department; investigating and analyzing problems; and correcting and preventing problems that meet CAPA conditions according to the procedure. However, the following were not provided: evidence of a retrospective review having been performed and evidence to document the implementation of training on the revised Customer Complaint Handling Procedures.1. 缺追溯性文件问题来源：Foshan R. Poon Medical Products Co. , LtdSubpart G Production and Process Controls 生产过程的控制 820.70 - Production and process controls. 生产过程的控制1. 厂家没有建立设备的维护计划，没有对设备建立保养计划及无法证明对设备进行定期维修和保养。问题来源：Merits Health Products Co., Ltd.2. 厂家没有建立并保持适当控制环境条件的程序，没有注意到灰层、垃圾和油污等对产品质量有不利影响。问题来源：EMG Manufacturing Co., Ltd3. 厂家并无验证控制环境条件的程序的有效性，且无进行定期检查环境控制系统。问题来源：EMG Manufacturing Co., Ltd4. 厂家没有建立工艺流程书问题来源：Heartway Medical Products Co., Ltd5. 产品主文档中产品设计验证的文件记录（包括验证方法、日期、实施验证的人）没有记录验证方法。问题来源：Heartway Medical Products Co., Ltd 820.72 - Inspection, measuring, and test equipment. 监视、测量和测试设备1. 厂家无建立校准程序2. 验证的标准没有在执行验证活动前被确认问题来源：Vega Technologies, Inc.的第1.b点3. 厂家只对FDA提出的问题生产设备进行校准和维护，但未提到对所有生产设备的校准和维护办法问题来源：Merits Health Products Co., Ltd 820.75 - Process validation. 生产过程确认1. The results of a process cannot be fully verified by subsequent inspection and test.过程的结果不能被随后的检验和试验完全验证问题来源：Merits Health Products Co., Ltd. 2. Failure to adequately ensure that, when the results of a process cannot be fully verified by subsequent inspection and test, 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). For example:2. 复杂的工序需要经过验证和审批问题来源：Foshan R. Poon Medical Products Co. , LtdWe reviewed your firms response and conclude that it is not adequate. While your firm provided a revised version of its Special Process Management Procedures, no validation reports for the (b)(4) process were provided, nor has your firm provided an analysis of any other special processes requiring validation. Additionally, there is no evidence of implementation or training on the revised procedure.3. 缺乏相关检验工序的验证报告问题来源：Foshan R. Poon Medical Products Co. , LtdSubpart H-Acceptance Activities验收活动Sec. 820.80 Receiving, in-process, and finished device acceptance. 原材料、半成品、成品的验收1. 厂家没有充分建立及维护成品验收程序问题来源：Merits Health Products Co., Ltd.2. 厂家无法保证单个或各批成品达到认可标准（问题来源：Merits Health Products Co., Ltd.） EMG Manufacturing Co., Ltd的第2点Subpart I-Nonconforming Product不合格品Sec. 820.90 Nonconforming product. 不合格品1. 厂家没有对规格不符的成品提供改善方案问题来源：Merits Health Products Co., Ltd.2. 厂家没有建立及维护返工控制程序，包括对不合格品返工之后的复试和复评问题来源：Merits Health Products Co., Ltd.3. 厂家对返工和复评行为没有记录在DHR文件中问题来源：Merits Health Products Co., Ltd.4. 厂家没有定义不合格产品的判定标准问题来源： Vega Technologies, Inc. 5. 当厂家对不合格产品的检验标准进行修订以后，没有对其他产品进行追溯性检验。（问题来源： Vega Technologies, Inc. 的第4点）Subpart J-Corrective and Preventive Action纠正和预防措施Sec. 820.100 Corrective and preventive action. 纠正和预防措施1. 厂家并没有建立及维护纠正预防措施的控制程序问题来源：Merits Health Products Co., Ltd. 问题来源：Vega Technologies, Inc. 1. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:问题来源：Foshan R. Poon Medical Products Co. , Ltd2. 厂家无法提供证据验证纠正和防止措施是否有效,并对成品器械无不利影响问题来源：Merits Health Products Co., Ltd. A. Your firms Management Procedures of Corrective and Preventive Measures, Document #NLR-QP-27, Revision C/0, does not include a requirement for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, nor does it include a requirement to document the corrective and preventive action showing implementation.问题来源：Foshan R. Poon Medical Products Co. , Ltd3. 纠正和预防措施的全部措施及结果没有记录在文件中，例如FDA提出厂家存在的问题后，厂家做出纠正后，并没将纠正措施记录在案，并检验其有效性。问题来源： Vega Technologies, Inc. 问题来源：Heartway Medical Products Co., LtdB. The investigator reviewed twelve Corrective and Preventive Actions (CAPAs) from 2011 and found that all twelve CAPAs lacked verification or validation prior to implementation and failed to contain or refer to documented evidence showing that the proposed corrective/preventive actions were implemented.问题来源：Foshan R. Poon Medical Products Co. , LtdC. Your firms data analysis procedure, Data Analysis Management Procedure, Document #NLR-QP-26, Revision C/0, is not complete because it only requires non-conforming products and customer satisfaction surveys to be analyzed. No other quality sources of data (e.g., complaints, medical device reports (MDRs), and internal/external audit results) were identified and required to be analyzed.4. 资料分析管理程序中数据分析需要各种类型的质量数据进行分析。问题来源：Foshan R. Poon Medical Products Co. , LtdWe reviewed your firms response and conclude that it is not adequate. While your firm provided evidence of its updated procedure, there is no evidence of a systemic corrective action, implementation of procedure, or training on either of the updated procedures.5. 没有体现更新的程序文件已经被贯彻执行。问题来源：Foshan R. Poon Medical Products Co. , LtdSubpart K-Labeling and Packaging Control标识和包装控制Sec. 820.120 Device labeling. 器械标签1. 厂家没有建立和保持控制标签程序问题来源：EMG Manufacturing Co., Ltd2. 厂家将品牌标签贴错问题来源：EMG Manufacturing Co., LtdOur inspection also revealed that the powered wheelchairs 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 under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(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 /MedicaiDevices/DeviceRegulationandGuidance/HowtoMarket1Your Device/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.问题来源：Foshan R. Poon Medical Products Co. , LtdSubpart MRecords记录Sec. 820.184 Device history record. 设备历史记录1. 厂家没有保留器械历史记录(DHRS)，也没有建立并保持关于保证各批或单个产品的DHR程序。问题来源：EMG Manufacturing Co., Ltd2. 厂家没有建立和维护产品的批次记录来证明制造产品与产品设计主文档一致。问题来源：Heartway Medical Products Co., Ltd3. 产品批次记录不完整（产品批次记录包括产品的生产日期、主要辨识贴纸、每批次的每台产品使用的辨识贴纸）问题来源：Heartway Medical Product