未按企业内部程序处理相关不符合项是企业最危险也是最不该

发生的事情，GMP(2010 版）第 184 条：所有药品的生产和包装均应按照

批准的工艺规程和操作规程进行操作并有相关记录，以确保药品达到规定的质
量标准，并符合药品生产许可和注册批准的要求。

2021 年 9 月，中国深圳某企业未按《不合格品控制程序》处

理，被 FDA 发出警告信。具体详情如下：

Warning Letter
警告信
Unimicro Medical Systems-Shenzhen Co., Ltd.
联合微创医疗器械（深圳）有限公司

January 6, 2022
2022 年 01 月 06 日
Dear Roly Lee:

During an inspection of your firm located in Shenzhen, China, on September

15, 2021, through September 26, 2021, an investigator from the United States Food
and Drug Administration (FDA) determined that your firm manufactures 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 any
function of the body.
2021 年 9 月 15 日至 9 月 26 日，美国食品和药物管理局（FDA）的一名
调查人员在对位于中国深圳的贵公司进行检查时，确定了贵公司生产 Veress 气
腹针。根据《联邦食品、药品和化妆品法案》（《法案》）第 201（h）节、
《美国法典》第 21 章第 321（h）条，因为它们用于诊断疾病或其他情况，或用
于治疗、缓解、治疗或预防疾病，或影响身体结构或任何功能，这些产品定义
为设备，。
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. These violations include, but are not limited to, the following:
本次检查表明，这些装置在法案第 501（h）节、《美国法典》第 21 卷
第 351（h）条的含义范围内掺假，因为其制造、包装、储存或安装所用的方法
或所用的设施或控制装置不符合联邦法规（CFR）第 820 部分 cGMP 的要求。
这些违规行为包括但不限于以下内容：

1. Failure to adequately establish and maintain procedures to control product

that does not conform to specified requirements as required by 21 CFR 820.90(a).
1.未能按照 21 CFR 820.90（a）的要求充分建立和维护程序，以控制不符
合规定要求的产品。
For example: Your firm has not established a disposition process for product
that does not conform to specified requirements. Your firm was not able to provide the
disposition of (b)(4) package heat sealed nonconforming products. In Nonconforming
Product Handling Sheet (No. (b)(4), dated (b)(4)), your firm noted (b)(4) package heat
sealing nonconformances. For these (b)(4) nonconforming products, the final
determination was stated as “return to warehouse” and no final disposition was
provided or conducted, per Nonconforming Product Control Procedure (Doc No. (b)
(4), Ver. (b)(4), and dated (b)(4)). Therefore, it is unknown where these products are
or how they were handled. Additionally, your firm’s staff was unaware of the
nonconforming product procedure or handling and disposition of nonconforming
products.
例如：贵公司尚未建立不符合规定要求的产品处置流程。贵公司无法提
供（b）（4）包装热封不合格产品的处置。在日期为（b）（4）的不合格品处
理单（编号（b）（4））中，贵公司注意到（b）（4）包装热封不合格。对于
这些（b）（4）不合格品，最终判定为“退回仓库”，未按照《不合格品控制
程序》（文件编号（b）（4））进行处理。因此，不知道这些产品在哪里，也
不知道它们是如何处理的。此外，贵公司的员工不知道不合格产品如何进行处
理和处置程序或不清楚不合格产品控制程序。
We have reviewed your firm’s response in the 483 Corrective Action Plan
dated October 8, 2021 and have concluded it is not adequate. You plan to stop any
products exporting to the United States of America until corrective actions are
completed and deactivate all products from your Device Listings until the corrective
actions are completed. You also plan to modify the Nonconforming Product Control
Procedure, train relevant personnel of the design, purchasing, quality, production,
warehouse, logistics, and sales department according to the revised procedure. You
state you will also perform retrospective review for all products which have been sold
for the US market, to analyze if there is any quality issue or adverse events that have
occurred. However, to ensure a sufficient evaluation of the risk posed by the situation,
you should also actively evaluate the risks associated with the device presently and
take any needed actions to mitigate those risks. This should not rely only on adverse
event reporting or other outside reporting. Additionally, your Corrective Action Plan
does not include ensuring the disposition of nonconforming products are documented.
As part of your corrective actions, you should document the disposition of the
identified nonconforming products.
我们已经审查了贵公司在 2021 年 10 月 8 日的 483 纠正行动计划中的回
应，并得出结论认为这是不够的。您计划停止向美国出口任何产品，并停用设
备列表中的所有产品，直到纠正措施完成。贵方还计划修改《不合格品控制程
序》，并根据修订后的程序培训设计、采购、质量、生产、仓库、物流和销售
部门的相关人员。您还将对已在美国市场销售的所有产品进行回顾性审查，以
分析是否存在任何质量问题或已发生的不良事件。然而，为了确保对这种情况
造成的风险进行充分评估，您还应该积极评估当前与设备相关的风险，并采取
任何必要的措施来缓解这些风险。这不应仅依赖不良事件报告或其他外部报告。
此外，您的纠正措施计划不包括确保记录不合格产品的处置。作为纠正措施的
一部分，您应记录已识别不合格产品的处置情况。
2. Failure to adequately establish and maintain 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).
2. 未 能 充 分 建 立 和 维 护 控 制 装 置 设 计 的 程 序 ， 以 确 保 符 合 21 CFR
820.30（a）的规定设计要求。
For example: Your firm was unable to provide documentation and/or evidence
of conducting Design and Development activities as described in the Design and
Development Control Procedures (Doc No. (b)(4), Ver. (b)(4), dated (b)(4)), related to
the veress pneumoperitoneum needles. In this document, the procedures for design
control are described in detail. The procedures include steps to review the design
input, output, verification and validation, design changes, design transfer, and design
history. However, your firm was unable to provide documentation and data
demonstrating design requirements for the veress pneumoperitoneum needles wet
met, as required by the Design and Development Control Procedures.
例如：贵公司无法提供与 veress 气腹针有关的设计和开发控制程序（文
件编号（b）（4），日期为（b）（4））。本文件详细描述了设计控制程序。
这些程序包括审查设计输入、输出、验证和确认、设计变更、设计转移和设计
历史的步骤。然而，贵公司无法按照设计和开发控制程序的要求，提供文件和
数据证明 veress 气腹针的设计要求。
We have reviewed your firm’s response in the 483 Corrective Action Plan
dated October 8, 2021 and have concluded it is not adequate. You plan to modify the
Design and Development Control Procedure based on the requirements of 21 CFR
820.30 Design Control, train all design personnel according to the revised procedure,
and to retrospectively review all products which have been sold for the U.S market, to
analyze if there is any quality issue or adverse events occurred. However, you have no
plan to evaluate the retrospectively conduct design control activities for affected
products. You should conduct a review of your products to determine which products
did not have design control activities conducted and retrospectively conduct those
activities to ensure products meet design requirements. In addition, you should
actively assess if lack of design control activities could have led to the distribution of
nonconforming products (aside from review of adverse event or malfunction reports).
If any risks are identified, you should take appropriate action to mitigate those risks.
我们已经审查了贵公司在 2021 年 10 月 8 日的 483 纠正行动计划中的回
应，并得出结论认为这是不够的。您计划根据 21 CFR 820.30《设计控制》的要
求修改《设计和开发控制程序》，根据修改后的程序培训所有设计人员，并回
顾性审查已向美国市场销售的所有产品，以分析是否存在任何质量问题或不良
事件。但是，您没有计划对受影响产品的设计控制活动进行回顾性评估。您应
该对产品进行审查，以确定哪些产品没有进行设计控制活动，并回顾性地进行
这些活动，以确保产品符合设计要求。此外，您应积极评估缺乏设计控制活动
是否可能导致不合格产品的分发（除了审查不良事件或故障报告）。如果发现
任何风险，您应该采取适当的措施来缓解这些风险。
3. Failure to adequately establish and maintain procedures for monitoring and
control of process parameters for validated processes to ensure that the specified
requirements continue to be met, as required by 21 CFR 820.75(b).
3.未能按照 21 CFR 820.75（b）的要求，充分建立和维护已验证过程的过
程参数监控程序，以确保继续满足规定的要求。
For example: Your firm was unable to provide validation documentation with
objective evidence and data for activities related to the manufacturing of medical
devices, specifically EtO Sterilization, Heat Sealing Packaging, and UV Glue Curing
documented in the Validation Management Control Procedure (Doc No. (b)(4), Ver.
No. (b)(4) and dated (b)(4)), Sealing Machine Sealing Effect Re-Verification Program
(Doc No. (b)(4), Ver. (b)(4) and dated (b)(4)), Sealing Machine Sealing Effect Re-
Verification Report (Doc No. (b)(4), Ver. (b)(4) and dated (b)(4)), UV Curing Re-
Verification Program (Doc No. (b)(4), Ver. (b)(4) and dated (b)(4)). Your firm also did
not have personnel familiar with process validation.
例如：贵公司无法提供与医疗器械制造有关的活动的客观证据和数据的
验证文件，特别是验证管理控制程序（文件编号（ b）（4），版本中记录的
EtO 灭菌、热封包装和 UV 胶水固化。编号（b）（4）和日期（b）（4）），
封口机密封效果再验证程序（文件编号（b）（4），版本（b）（4）并注明日
期（b）（4）），密封机密封效果再验证报告（文件号（b）（4），版本（b）
（4）并注明日期（b）（4）），UV 固化再验证计划（文件号（b）（4），版
本（b）（4）和日期（b）（4））。贵公司也没有熟悉工艺验证的人员。
We have reviewed your firm’s response in the 483 Corrective Action Plan
dated October 8, 2021 and have concluded it is not adequate. You plan to modify the
validation management control procedure based on the requirement of 21 CFR 820.75
Process validation, train all validation personnel according to the revised procedure,
re-validate all other special processes identified for U.S products such as the
ultrasonic cleaning process and ultrasonic welding process, and re-validate the EtO
sterilization process, heat sealing packaging process, and UV glue curing process.
However, these activities have not been completed. In addition, you have not
indicated if or how you plan to assess any potential impacts of the lack of process
validation on previously distributed product and how you plan to mitigate any
associated risks. To ensure safety and conformity of product, it is important that you
assess the potential impact the lack of process validation as described above, may
have had on previously distributed products as part of your corrective action plan.
我们已经审查了贵公司在 2021 年 10 月 8 日的 483 纠正行动计划中的回
应，并得出结论认为这是不够的。您计划根据 21 CFR 820.75《工艺验证》的要
求修改《验证管理控制程序》，根据修订后的程序培训所有验证人员，重新验
证所有其它提供给美国的产品的特殊过程，如超声波清洗过程和超声波焊接过
程，并重新验证 EtO 灭菌过程，热封包装工艺，UV 胶固化工艺。然而，这些
活动尚未完成。此外，您还未说明是否或如何计划评估缺乏工艺验证对之前分
发的产品的任何潜在影响，以及如何计划缓解任何相关风险。为确保产品的安
全性和一致性，作为纠正措施计划的一部分，您必须评估缺乏上述过程验证可
能对之前分发的产品产生的潜在影响。
4. Failure to adequately establish and maintain procedures for implementing
corrective and preventive action as required by 21 CFR 820.100(a).
4.未能按照 21 CFR 820.100（a）的要求充分建立和维护实施纠正和预防
措施的程序。
For example: Your firm did not provide a severity determination, or a root
cause analysis conducted for CAPA events deemed “necessary”. The CAPA states a
root cause analysis is required to be conducted only if necessary. However, your firm
has not defined what CAPA events are necessary in the Corrective and Preventive
Actions Control Procedure (Doc No. (b)(4) Ver. (b)(4) dated (b)(4)). In the document,
your firm utilizes an in-process CAPA, which requires a severity determination, which
is not defined in the procedure. There is no documented definition, requirement, or
guidance in the procedure for the severity determination. Also, no root cause analysis
was performed in your firm’s two most recent CAPAs, (Abnormal Manufacturing
Process Feedback Memo (b)(4) for Model MND11500 and Model MND11200).
例如：贵公司没有提供严重性判定标准，也没有对被认为“必要”的
CAPA 事件进行根本原因分析。CAPA 规定，只有在必要时才需要进行根本原因
分析。然而，贵公司尚未在纠正和预防措施控制程序（文件编号（b）（4）版
本）中定义哪些 CAPA 事件是必要的。（b）（4）日期（b）（4））。在该文
件中，贵公司使用了过程中 CAPA，这需要确定严重性，但程序中没有定义。
严重性确定程序中没有记录在案的定义、要求或指南。此外，贵公司最近的两
份 CAPA（MND11500 型和 MND11200 型的异常制造过程反馈备忘录（ b）
（4））中未进行根本原因分析。
We have reviewed your firm’s response in the 483 Corrective Action Plan. The
adequacy of the response dated October 8, 2021, cannot be determined at this time.
You plan to modify the Corrective and Preventive Action Control Procedure to define
severity (Major, Moderate, or Minor), and define what is “necessary” when requiring
a root cause analysis. You intend to train relevant personnel of all departments
according to the revised procedure. You also state you will investigate the past CAPAs
and customer complaints, to confirm whether there is any improper handling of
CAPAs or customer complaints, and to evaluate the risks to the products that have
been sold in the US market. These actions have not been completed; therefore, the
adequacy of these actions cannot be determined until the activities described have
been completed and documentation verifying the successful completion of these
actions are provided.
我们已经审查了贵公司在 483 纠正行动计划中的回应。目前无法确定
2021 年 10 月 8 日的回复是否充分。您计划修改纠正和预防措施控制程序，以定
义严重性（严重、中度或轻微），并定义需要进行根本原因分析时“必要”的
内容。您打算按照修订后的程序培训各部门的相关人员。您还声明将调查过去
的 CAPA 和客户投诉，以确认是否存在对 CAPA 或客户投诉的不当处理，并评
估已在美国市场销售的产品的风险。这些行动尚未完成；因此，在完成所述活
动并提供证明这些行动成功完成的文件之前，无法确定这些行动的充分性。
5. Failure to adequately establish and maintain procedures to ensure that
equipment is routinely calibrated, inspected, checked, and maintained as required by
21 CFR 820.72(a).
5.未能充分建立和维护程序，以确保设备按照 21 CFR 820.72（a）的要求
进行常规校准、检查、检查和维护。
For example: Your firm was not able to provide calibration documentation and
data related to equipment and instruments including leakage tester and push & pull
tester, used in the manufacturing of medical devices intended for the US market. Your
firm was able to provide the calibration procedure, Production Equipment
Management Control Procedure (Doc No. (b)(4), Ver. (b)(4), and dated (b)(4)).
However, when calibration documentation for equipment and instruments used during
the manufacturing of the Class II Veress Needles, such as their Leakage Tester and
Push & Pull Tester, your firm was unable to provide calibration documentation and
data.
例如：贵公司无法提供与设备和仪器（包括泄漏测试仪和推拉测试仪）
相关的校准文件和数据，这些设备和仪器用于制造面向美国市场的医疗器械。
贵公司能够提供校准程序、生产设备管理控制程序（文件编号（b）（4），版
本（b） （4）和日期（b）（4））。然而，在制造 II 类 Veress 针头期间使用的
设备和仪器的校准文件，如泄漏测试仪和推拉测试仪时，贵公司无法提供校准
文件和数据。
We have reviewed your firm’s response in the 483 Corrective Action Plan. The
adequacy of the response dated October 8, 2021, cannot be determined at this time.
You plan to modify the production equipment management control procedure based
on the requirements of 21 CFR 820.72(a) and train relevant personnel of quality,
production, and warehouse departments according to the revised procedure. You also
plan to send Leakage Tester and Push&Pull Tester to the Calibration institute for
calibration. Additionally, you state that you will review the impact of their Leakage
Tester and Push&Pull Tester on the product test results during the failure period based
on the calibration results. Lastly, you plan to review the measuring and test equipment
for any of the same issues for other inspection, measuring, and test equipment. These
actions have not been completed; therefore, the adequacy of these actions cannot be
determined until the activities described have been completed, and documentation
verifying the successful completion of these actions are provided.
我们已经审查了贵公司在 483 纠正行动计划中的回应。目前无法确定
2021 年 10 月 8 日的回复是否充分。贵方计划根据 21 CFR 820.72（a）的要求修
改《生产设备管理控制程序》，并根据修改后的程序培训质量、生产和仓库部
门的相关人员。您还计划将泄漏测试仪和推拉测试仪送至校准机构进行校准。
此外，您声明，您将根据校准结果，在故障期间审查其泄漏测试仪和推拉测试
仪对产品测试结果的影响。最后，您计划针对其他检查、测量和测试设备的任
何相同问题，检查测量和测试设备。这些行动尚未完成；因此，在完成所述活
动并提供证明这些行动成功完成的文件之前，无法确定这些行动的充分性。
 6. Failure to adequately establish and maintain acceptance procedures, where
appropriate, to ensure that specified requirements for in-process product are met as
required by 21 CFR 820.80(c).
在适当情况下，未能充分建立和维护验收程序，以确保符合 21 CFR
820.80（c）中对过程中产品的规定要求。
For example: Your firm’s Veress Needle Quality Inspection Standard (Doc No.
(b)(4), Ver. (b)(4), dated (b)(4)) is not adequately established, as the quality control
personnel were conducting in-process acceptance activities that did not include
connection bond testing, and puncture testing of the subject device. Your firm has not
established and maintained in-process acceptance activity procedures to ensure
specified requirements for in-process products are met. The quality personnel were
conducting acceptance activities based on the Inspection Standard used to conduct in-
process acceptance activities for the Veress Needles. However, according to the
investigator, your firm’s quality staff conducting the in-process acceptance activities
were not familiar with the testing process and stated there were no established in-
process acceptance procedures for the connection bond and puncture testing.
However, in the Semi-Finished Inspection Record ((b)(4)), there is a requirement
included to conduct a connection bond test and puncture test, that the quality staff
conducting the in-process acceptance activities were not familiar with. The
requirement listed in the semi-finished inspection record was not included in the final
Veress Needle Quality Inspection Standard.
例如：贵公司的 Veress 针头质量检验标准（文件编号（b）（4），版本
（b）（4），日期为（b）（4））未充分确定，因为质量控制人员正在进行过
程中验收活动，其中不包括对受试设备的连接粘结测试和穿刺测试。贵公司尚
未建立和维护过程中验收活动程序，以确保满足过程中产品的规定要求。质量
人员根据用于对 Veress 针头进行过程中验收活动的检验标准进行验收活动。然
而，据调查人员称，贵公司进行过程中验收活动的质量人员不熟悉测试流程，
并表示没有针对粘结测试和穿刺测试建立过程中验收程序。然而，在半成品检
验记录（（b）（4））中，有一项要求包括进行连接粘结试验和穿刺试验，这
是进行过程中验收活动的质量人员不熟悉的。半成品检验记录中列出的要求未
包含在最终的 Veress 针质量检验标准中。

We have reviewed your firm’s response in the 483 Corrective Action Plan
dated October 8, 2021, and have concluded it is not adequate. You plan to modify the
Veress Needle Quality Inspection Standard and all other quality inspection standards,
train relevant personnel of the quality and production department according to the
revised Quality Inspection Standards, and perform retrospective review for all
products which had been sold for the U.S market, to analyze if there is any quality
issue or adverse event occurred. These actions have not been completed. In addition,
your firm has not identified plans to evaluate their document control system, to make
changes to ensure the requirements are consistent across documents. To ensure
conformance to the standard across all relevant in-process acceptance activities, you
should evaluate your document control system as part of your corrective action plan.
我们已经审查了贵公司在 2021 年 10 月 8 日的 483 纠正行动计划中的回
应，并得出结论认为这是不够的。您计划修改 Veress 针头质量检验标准和所有
其他质量检验标准，根据修订后的质量检验标准培训质量和生产部门的相关人
员，并对所有已销往美国市场的产品进行回顾性审查，以分析是否有任何质量
问题或不良事件发生。这些行动尚未完成。此外，贵公司尚未确定评估其文件
控制系统的计划，以进行更改以确保各文件的要求一致。为了确保在所有相关
的过程验收活动中符合标准，您应该评估您的文件控制系统，作为纠正措施计
划的一部分。
7. Failure to adequately establish and maintain procedures to ensure that
DHR's for each batch, lot, or unit are maintained to demonstrate that the device is
manufactured in accordance with the DMR, and the requirements of this part as
required by 21 CFR 820.184
7.未能充分建立和维护程序，以确保每个批次或单元的 DHR 得到维护，
以证明设备是按照 DMR 以及 21 CFR 820.184 的要求制造的
For example: Your firm was not able to provide Device History Records for
their manufactured medical devices intended and exported to the US market. Your
firm was unfamiliar with FDA regulations and requirements for manufactures to
include the DHR requirements and their Device History Record Control Procedures
(Doc No. (b)(4), Ver. (b)(4) and dated (b)(4)).
例如：贵公司无法提供拟出口至美国市场的医疗设备的设备历史记录。
贵公司不熟悉 FDA 法规和制造商要求，包括 DHR 要求及其设备历史记录控制
程序（文件编号（b）（4），版本（b）（4）和日期（b）（4））。
We have reviewed your firm’s response in the 483 Corrective Action Plan. The
adequacy of the response dated October 8, 2021, cannot be determined at this time.
You state you intend to modify their DHR control procedures based on the
requirements of 21 CFR 820.184 and perform sample inspection of (b)(4) batches of
the subject device based on the revised procedure, to confirm the integrity and
correctness of the DHRs. You also plan to train relevant personnel on design,
purchasing, quality, production, warehouse, logistics, PMC, and sales department
according to the revised procedures and your firm plans to perform a retrospective
review for all products which had been sold for the US market. These actions have not
been completed; therefore, the adequacy of these actions cannot be determined until
the activities described have been completed and documentation verifying the
successful completion of these actions are provided.
我们已经审查了贵公司在 483 纠正行动计划中的回应。目前无法确定
2021 年 10 月 8 日的回复是否充分。您表示打算根据 21 CFR 820.184 的要求修改
DHR 控制程序，并根据修改后的程序对（b）（4）批受试设备进行抽样检查，
以确认 DHR 的完整性和正确性。贵公司还计划根据修订后的程序对相关人员进
行设计、采购、质量、生产、仓库、物流、PMC 和销售部门方面的培训，贵公
司计划对所有已在美国市场销售的产品进行回顾性审查。这些行动尚未完成；
因此，在完成所述活动并提供证明这些行动成功完成的文件之前，无法确定这
些行动的充分性。
8. Failure to maintain device master records (DMRs) as required by 21 CFR
820.181.
 8.未能按照 21 CFR 820.181 的要求维护设备主记录（DMR）。
For example: Your firm has not maintained their Device Master Records
related to the subject device, and the personnel was unfamiliar with documents,
processes, and medical devices related to the U.S market. Additionally, the manager
of the site was not familiar with the FDA regulatory requirements to include DMRs
for medical device manufacturers.
例如：贵公司没有保存与受试设备相关的设备主记录，人员不熟悉与美
国市场相关的文件、流程和医疗设备。此外，该场所的经理不熟悉 FDA 的监管
要求，包括医疗器械制造商的 DMR。
We have reviewed your firm’s response in the 483 Corrective Action Plan. The
adequacy of the response dated October 8, 2021, cannot be determined at this time.
You plan to output DMRs according to the reorganized Device History File for all
products exported and intended for the U.S market, and to retrospectively review for
all products which have been sold for the US market, to analyze if there are any
quality issues or adverse events that have occurred. These actions have not been
completed; therefore, the adequacy of these actions cannot be determined until the
activities described have been completed and documentation verifying the successful
completion of these actions are provided.
我们已经审查了贵公司在 483 纠正行动计划中的回应。目前无法确定
2021 年 10 月 8 日的回复是否充分。您计划根据已重组的设备历史文件，为所有
出口并打算进入美国市场的产品输出 DMR，并对所有已进入美国市场的产品进
行回顾性审查，以分析是否存在任何质量问题或不良事件。这些行动尚未完成；
因此，在完成所述活动并提供证明这些行动成功完成的文件之前，无法确定这
些行动的充分性。
Given the serious nature of the violations of the Act, 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 corrected. In order to remove the devices from detention, your firm
should provide a written response to this Warning Letter as described below and
correct the violations 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.
鉴于违反该法案的严重性质，贵公司生产的 Veress 气腹针可能会根据该
法案第 801（a）节、《美国法典》第 21 卷第 381（a）条的规定被拒绝入境，
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，
称为“未经检验的扣押”，直到这些违规行为得到纠正。为了将这些装置从扣
押中移除，贵公司应按照下文所述对本警告信做出书面回复，并纠正本信中所
述的违规行为。我们将通知您贵公司的回复是否充分，以及是否需要重新检查
贵公司的设施，以验证是否已采取适当的纠正和纠正措施。
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 确定您存在与 III 类器械上市前批准申请合
理相关的违反质量体系法规的行为，在违规行为得到解决之前，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 correct 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.
请在收到本函之日起十五个工作日内书面通知本办公室，说明贵公司为
纠正上述违规行为而采取的具体措施，并说明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。包括贵公司已采取的纠正和纠正措施（必须解决
系统性问题）的文件。如果贵公司计划的纠正和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。如果纠正和纠正措施无法在 15 个工作日
内完成，请说明延迟的原因以及完成这些活动的时间。
Your firm's response should be comprehensive and address all 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. Please provide a translation of documentation
not in English to facilitate our review.
贵公司的回复应全面，包括处理本警告信中包含的所有违规行为。如果
您认为您的产品没有违反 FD&C 法案，请将您的理由和任何支持信息作为您回
复的一部分，供我们考虑。请提供非英语文件的翻译，以便于我们审查。
Your firm's response should be sent to
CDRHWarningLetterResponses@fda.hhs.gov, or if e-mail cannot be used:

Food and Drug Administration - CDRH/ORP/DRP2

CDRH Regulatory Inspections and Audit Team, WO66-1434
10903 New Hampshire Ave.
Silver Spring, MD 20993

Refer to CMS case #424228 when replying. If you have any questions about
the contents of this letter, please contact: OHT Assistant Director, Jason Roberts at
jason.roberts@fda.hhs.gov or (240)402-6400

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 the violations, and take prompt actions to correct the
violations and bring the products into compliance.
最后，您应该知道，这封信并没有列出贵公司工厂的所有违规行为。贵
公司有责任确保遵守 FDA 管理的适用法律法规。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制造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违规原因，并立即采取措施纠正违规行为，
使产品符合规定。
Sincerely Yours,
/S/

Courtney H. Lias, Ph.D.

Office Director
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC:
Zeyu Chen
238 Fernwood Ave, Edison, NEW JERSEY 08837