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Warning letter warning signs

This article was originally published in The Tan Sheet

Executive Summary

Non-standard language at the end of manufacturing warning letters is a red flag that FDA may be considering more serious enforcement action, Sidley Austin Brown & Wood Partner Raymond Bonner said during an April Drug & Device Dialogue audio conference. F-D-C Reports/Poladais-sponsored "GMP Enforcement v. Global Supply: Lessons from GSK, Chiron and Others" is available on CD at 1www.drugdevicedialogue.com or by calling 1-800-332-2181...
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