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FDA to review company responses to inspection reports

This article was originally published in The Silver Sheet

Executive Summary

FDA will now consider manufacturer responses to FDA-483 inspection forms received within 15 days of the form's issuance when deciding whether to send a warning letter, FDA says in an Aug. 11 Federal Register notice. However, the agency notes that timely responses will not necessarily preclude it from issuing a warning letter. And the 15-day response deadline is firm: "The agency 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," the FR notice says. FDA plans to test out the response review program for 18 months and then decide whether to make it permanent
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