FDA Says You Only Have 15 Days To Respond To Form 483

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Updated September 7, 2021

The links broke in the original post.

You can still read about the topic here:

The Emergency Guide To FDA Warning Letters & FDA 483. How to handle inspectional observations and warning letters from the FDA. A White Paper by The FDA Group LLC.

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According to this PharmTech article, FDA Begins Enforcing Deadlines on Form 483 Responses, you have only 15 days to respond to a form 483. Be aware, this article states:

Now, however, FDA “will not ordinarily delay the issuance of a warning letter in order to review a response to an FDA 483 that is received more than 15 business days after the FDA 483 was issued,” according to an announcement in the Federal Register.

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