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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Post-inspection response program: Beginning Sept. 15, FDA will consider industry responses to Form 483 inspection reports received within 15 days of the report's release when deciding whether to send a warning letter, FDA explains in an Aug. 11 Federal Register 1notice. Timely responses do not preclude FDA from issuing a warning letter. FDA Commissioner Margaret Hamburg announced the 15-day post-inspection deadline for company responses to FDA's inspection findings at a Food and Drug Law Institute meeting Aug. 6 (2"The Gray Sheet" Aug. 10, 2009). FDA plans to test out the response review program for 18 months and then decide whether to implement it permanently
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