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...