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FDA Drug GMP Warning Letters Increase 6%, Focus on Supply Chain and Sterility Assurance in FY 2011

This article was originally published in The Gold Sheet

Executive Summary

The number of drug GMP warning letters issued by FDA continued to climb in fiscal year 2011, with supply chain and sterility assurance issues dominating the agency’s attention. FDA is requesting a budget increase in FY 2013 to expand its inspectional presence abroad to better meet global supply chain threats, and agency officials are saying that failure to monitor contract manufacturers is a major problem shown in recent warning letters, but that failure to investigate out-of-specification results is still the No. 1 finding.

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