一千零一夜 0012 FDA 483表常见问题问答

483表即现场观察报告“Inspectional Observations”，这份表格编号是“Form FDA 483”，因此习惯称之为483表。483表一般是不公开的，只有企业自己收到。除非FDA认为有必要，会在FDA官网公开部分483。

FDA Form 483 Frequently Asked Questions

FDA 483 表的常见问题问答

Q: When is an FDA Form 483 issued?

问题：FDA 何时签发483 表？

A: An FDA Form 483 is issued to firm management at the conclusion of an

inspection when an investigator(s) has observed any conditions that in

their judgement may constitute violations 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. Observations are made when in the investigator’s judgement,

conditions or practices observed would indicate that any food, drug,

device or cosmetic has been adulterated or is being prepared, packed,

or held under conditions whereby it may become adulterated or rendered

injurious to health.

答：FDA 检查人员发现某些问题时，根据他们的判断，这些问题可能违反了

FD&C法案 和相关法案，在检查结束时，会签发一份FDA483 表给公司管理层。FDA 检查人员培训时要求确保FDA483 表上提到的每个问题是清楚的、具体的和具有显著意义的。根据检查人员的判断，这些问题、情况和行为表明食品、药品、医疗器械和化妆品被掺假，或者在某些情况下制备、包装和保存而导致产品被掺假或者对健康有伤害。

Q: What is the purpose of an FDA Form 483?

问题：签发483 表的目的是什么？

A: The FDA Form 483 notifies the company’s management of objectionable conditions. 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.

答：FDA483 表的目的是通知公司管理层不良的情况。在检查结束时，FDA483 表会提出来并和公司高层管理层进行讨论。鼓励被检查公司以书面形式回复FDA483 表，包括他们的纠正行动计划和随后对纠正行动的快速实施情况。

Q: Is the FDA Form 483 intended to be an all-inclusive list of every

possible deviation from law and regulation?

FDA483 表是否是一个从法律和法规层面对每个可能偏差的包含一切的目录？

A: No, it’s not. The FDA Form 483 is a report which does not include

observations of questionable or unknown significance at the time of the

inspection. There may be other objectionable conditions 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 responsible to take corrective action to address the cited objectionable conditions and any related non-cited

objectionable conditions that might exist.

答：不是，不是这样的。FDA483 表是一份报告，它不包括检查时发现的存疑

的问题或者具有未知意义的问题。有可能被检查公司存在有其他不良情况没有

包含在FDA483 表中。要求FDA 检查人员只是提出他们检查过程中看到的问

题。被检查公司有责任采取纠正行动来处理被提到的问题，和任何没有被提到的

可能存在的不良情况。

Q: How is the FDA Form 483 shared with the company?

FDA483 表是如何和被检查公司分享的？

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 observations are and

what they mean.

答：在检查最后会议时，FDA483 表会拿来和公司管理层进行讨论。介绍每个

发现的问题并讨论，以便有充分的理解，这些问题是什么？这些问题意味着什

么？

Q: What are the implications of the FDA Form 483 for agency enforcement

and what happens next?

FDA483 表对FDA 强制行动有什么暗示作用？随后会发生什么？

A: The FDA Form 483 does not constitute a final Agency determination of

whether any condition is in violation of the FD&C Act or any of its

relevant regulations. The FDA Form 483 is considered, along with a

written report called an Establishment Inspection Report, all evidence

or documentation collected on-site, and any responses made by the

company. The Agency considers all of this information and then

determines what further action, if any, is appropriate to protect public

health.

答：FDA483 表不构成FDA 最后的决定，关于那些情况是否违反了FD&C 或者违反了FD&C 的任何相关法规。FDA483 表连同称为EIR 的书面报告，现场收集的所有证据和文件以及任何被检查公司做出的反应，应予以考虑。FDA 考虑全部这些信息，然后确定进一步行动，如果有的话，对于保护公众健康是合适的。