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In Brief: FDA warning letter grace period

This article was originally published in The Gray Sheet

Executive Summary

FDA warning letter grace period: Proposal to give firms a 15-day response period after receiving an FDA-483 inspectional observation form prior to issuing a warning letter is slated for discussion at an April meeting of FDA's Field Committee. The change in policy would obviate issuance of a warning letter if a firm corrected all violations during the grace period ("The Gray Sheet" Dec. 22, I&W-5)...
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