FDA Tightens Deadlines on Form 483 Responses

The FDA has moved to significantly tighten and speed up its enforcement efforts, including limiting which warning letters must be reviewed by its chief counsel and giving companies no more than 15 business days to respond to serious inspection results.

Delays and multiple responses to Form 483 observations have hindered the issuance of warning letters, the FDA says in its new enforcement plan published last month in the Federal Register.

The agency will conduct a detailed review of a manufacturer’s response to a Form 483 — if it is received within 15 business days — before determining whether to issue a warning letter, according to the plan.
The GMP Letter