Manufacturer response to form FD-483 within 15 days could preclude warning letter -- FDA/industry proposal.
This article was originally published in The Gray Sheet
Executive Summary
MANUFACTURERS WOULD HAVE 15 DAYS TO FORESTALL WARNING LETTERS after receiving an FD-483 inspectional observations form under a proposal being considered by FDA. The change in policy would respond to manufacturer complaints that FDA issues warning letters even when companies fully address deficiencies in their 483 responses.