FDA483表与警告信的常见问题回答

                  FDA483表与警告信的常见问题回答
来源：网络知识汇总

Q: When is an FDA Form 483 issued? 什么时候签发FDA483表？

A: An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditi** that in their judgement may c**titute violati** of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observati** are made when in the investigator’s judgement, conditi** or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditi** whereby it may become adulterated or rendered injurious to health.

在FDA现场检查中，如果检查官发现任何他/她认为构成违反食品药品化妆品法案的情形时，将签发FDA483表格给受检公司管理层，在其中说明检查结果。FDA检查官受到培训，会保证在FDA483表格中所列的每个缺陷都是清楚的、指向明确的以及重大的。根据检查官的判断，表中记录的缺陷、所观察到的情形或操作实践说明已经或正在生产、包装、持有食品、药品、医疗器械或化妆品是假药或可能形成假药，或会对健康构成伤害。

Q: What is the purpose of an FDA Form 483? FDA483表的目的是什么？

A: The FDA Form 483 notifies the company’s management of objectionable conditi**. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.

FDA483表格的目的是通知公司管理层这些不好的情况。根据检查的结果，检查官填写提交FDA483表格，并与公司高层管理人员进行讨论。FDA鼓励公司采用书面方式，将其对FDA483表中缺陷所制订的CAPA回复给FDA，然后迅速实施这些纠正措施计划。

Q: Is the FDA Form 483 intended to be an all-inclusive list of every possible deviation from law and regulation? FDA483表是否包括了所有可能的违规方面？

A: No, it’s not. The FDA Form 483 is a report which does not include observati** of questionable or unknown significance at the time of the inspection. There may be other objectionable conditi** that exist at the firm that are not cited on the FDA Form 483. FDA investigators are instructed to note only what they saw during the course of the inspection. Companies are resp**ible to take corrective action to address the cited objectionable conditi** and any related non-cited objectionable conditi** that might exist.

不是。FDA483表格是一份报告，它并不包括检查时有疑问或未发现的缺陷情况。可能公司还存在一些其它的违规行为，但并没有在FDA483表中列出。FDA检查官被要求只能记下他们在检查期间所看到的缺陷。公司有责任采取纠正措施来说明被指出的违规情形，以及所有有关的、可能存在的但并未指出的违规情形。

Q: How is the FDA Form 483 shared with the company? FDA483表如何提交给公司？

A: FDA Form 483s are discussed with a company’s management at the conclusion of the inspection. Each observation is read and discussed so that there is a full understanding of what the observati** are and what they mean.

在检查得出结果时，检查官会就FDA483表与公司管理人员进行讨论。检查官会将缺陷逐一讨论，保证受检公司明白这些缺陷是什么，以及为什么是缺陷。

Q: What are the implicati** of the FDA Form 483 for agency enforcement and what happens next? FDA483表与药监机构采取措施之间有什么关系？FDA483表之后会发生什么事情？

A: The FDA Form 483 does not c**titute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulati**. The FDA Form 483 is c**idered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any resp**es made by the company. The Agency c**iders all of this information and then determines what further action, if any, is appropriate to protect public health.

FDA483表并不是药监当局关于该受检场所是否违反食品药品化妆品法案及其它相关法规的最终决定。FDA483表与书面的EIR报告、在工厂收集的所有证据和文件记录，以及由公司做出的所有回复一起构成证据链。FDA将会综合考虑这些信息，然后决定是否需要采取进一步适当的行动来保证公众健康。

General FDA Warning Letters

常规FDA警告信

When FDA finds that a manufacturer has significantly violated FDA regulati**, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directi** for use. The letter also makes clear that the company must correct the problem and provides directi** and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s correcti** are adequate. Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the recipient of the letter that may have changed the regulatory status of the issues discussed in the letter.

当FDA发现一个生产商严重违反FDA法规时，FDA会通知生产商。该通知一般采用警告信的方式。该警告信会界定违规行为，例如，生产规范太差、产品问题、错误的使用说明。警告信还会说明公司必须纠正该问题，并对公司给出指令和一个时间限制，要求其在此时限内向FDA提交其纠正计划。之后FDA会进行检查，以保证公司的纠正措施是充分的。在FDA警告信中描述的问题会在随后FDA与受检公司之间进行沟通，后期公司回复信件可能会改变当时在警告信中所讨论的法规情形。

Warning Letter Close-Out Letter Program (applies to letters issued on or after Sept. 1, 2009)

警告信关闭函程序

FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective acti** undertaken by a firm in resp**e to a Warning Letter. A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violati** contained in the Warning Letter. This procedure applies to Warning Letters issued on or after September 1, 2009.

一旦FDA完成了公司对警告信回复的纠正措施的评估，则可能会签发一封警告信关闭函。如果公司已针对警告信中的包括的违规行为采取了纠正措施，根据FDA的评估，FDA可能会签发一份关闭函。该程序适用于2009年9月1日起签发的警告信。

A close-out letter will not be issued based on representati** that some action will or has been taken. The corrective acti** must actually have been made and verified by FDA. Usually, the standard for verifying that correcti** have been implemented will be a follow-up inspection. If the Warning Letter contains violati** that by their nature are not correctable, then no close-out letter will issue. Future FDA inspecti** and regulatory activities may further assess the adequacy and sustainability of these correcti**. Should violati** be observed during a subsequent inspection or through other means, enforcement action may be taken without further notice. The FDA office that issued the Warning Letter will issue the close-out letter, and that office may be contacted for information on a particular Warning Letter.

在看到某些措施已经实施或即将实施时，FDA不会签发关闭函。纠正措施必须实际已全部完成，并由FDA现场核实。一般来说，对已实施的纠正措施的核实标准是跟踪检查。如果警告信中包括的违规行为是无法纠正的，则不会签发关闭函。将来，FDA检查和法规行为可能会进一步评估这些纠正措施的充分性和持续性。如果在随后检查中或通过其它方式发现违规行为，则会在不再发布通知而直接采取强制措施。签发警告信的FDA办公室会签发关闭函，如有关于某特定的警告信的信息问题，可以联系当地FDA办公室。