20150715 ECA新闻：FDA检查报告：什么是什么

20150715 ECA新闻：FDA检查报告：什么是什么

GMP News
15/07/2015

FDA Inspection Reports: What is What

FDA检查报告：什么是什么

Repeatedly we receive questions with regard to the various inspection reports of the U.S. Food and Drug Administration (FDA). Following we will introduce the three main documents:

我们不断收到关于美国FDA不同检查报告的问题。以下我们将介绍三种主要的文件：

Form 483  #483表格

This form with the eponymous number 483 is used by the executing Inspector (FDA Investigator) to document the deficiencies he found. It is issued at the end of the inspection and should be answered officially. This response is expected within 15 working days after its issuance. Only then it is guaranteed that the statement will be taken into account in a possible Warning Letter (see below). Sometime, in the case of reasonable compliance, no 483 is issued.

483表格用于执行检查的检查员（FDA调查员）记录其所发现的缺陷。在检查结果时检查员要签发该表格，受检企业则需要对其中缺陷进行正式回复。对该表格中缺陷的回复需要在其签署后的15个工作日内提交。只有在收到回复后，才会可能做出决定是否签发警告信（见下）。有时，在达到合理符合的情况下，没有483表格签出来。

EIR: Establishment Investigation Report 工厂调查报告

The EIR is also created by the Inspector in addition to the form 483. This should be done within 30 working days. The EIR is then examined by the responsible Center or District Office of the FDA, issuing the following statuses:

除了483表以外，检查员还要制作EIR。EIR要在30个工作日内完成，然后交由FDA地区办公室或中央办公室负责人检查，检查后会被识别为以下几种状态：

• NAI: No Action Indicated - there were no objectionable items found during the inspection
  
• NAI：不需要采取措施---在检查期间没有发现违规项目
  
• VAI: Voluntary Action Indicated - objectionable items were found, but no action is required on the part of the authority. All of the company's actions are on a voluntary basis.
  
• VAI：自愿采取措施---发现了违规项目，但不需要官方采取行动。公司的所有行为都是基于自愿的。
  
• OAI: Official Action Indicated - objectionable items were found and further regulatory measures will be derived (e.g. Warning Letter).
  
• OAI：官方需采取行动—发现违规项目，需要采取进一步法规措施（例如警告信）
  
  

The EIR is forwarded to the inspected company. As part of the so-called 'Freedom of Information Act' it can also be requested by other companies, though. But experience has shown that the disclosure of a foreign EIR may take some time.

FDA会将EIR发给受检公司。作为所谓“信息自由法案”的一部分，其它公司也可以申请查看EIR。但经验显示公布国外EIR要花费相当长时间。

Warning Letter 警告信

This is mainly issued when serious defects were identified but also if the answer to the Form 483 is classified as inadequate. It is released - after a review by the responsible Center/ District Offices, not the Inspector himself. The company must respond within 15 working days and explain in detail how to resolve the deficiencies on the one hand and how a recurrence can be prevented on the other hand. Warning Letters are generally published on the homepage of the FDA.

如果检查中发现了严重缺陷，且对483表格的回复被认为是不充分的，则FDA会签发警告信。公司必须在15个工作日内进行回复，详细解释如何解决这些缺陷，以及如果防止其再次发生。警告信一般在FDA官网上发布。

In the aftermath,  other unpleasant consequences for the company may apply:

之后公司可能会面临以下恶果：

• Influence on the approval 对批准的影响
  The authorisation for one or more products will not be granted. Applications will not be processed.
• 将停止颁发一个或多个药品的批准。停审申报资料。
  
• Import Stop / FDA Import Alert 进口中止/FDA进口禁令
  The company's product (or products) may no longer be imported into the United States. The goods remain at customs.
  
• 公司的产品可能不能再出口至美国。产品将被扣留在海关。
  
• Debarment List  黑名单
  This list comprises all persons who are not allowed to produce pharmaceutical products for the American market. The Debarment List is freely available.
  
• 该清单包括了所有不允许生产销往美国的药品的人员。黑名单是公开的。
  
• Court - Consent Decree 法院---同意令
  For American companies and its subsidiaries it can be obtained legally that for several months to years a consulting company will check the company and streamline systems and processes. A final inspection is carried out at the end. In the meantime, profits can be skimmed off.
• 对于美国公司及其分公司，可以能会需要有一个顾问公司对公司进行几个月到几年的检查，并改进系统和流程。结束后会进行检查，同时会失去利润。
  
  

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