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FDA’S DRUG GMP WARNING LETTER USAGE

This article was originally published in The Gold Sheet

Executive Summary

...remained low in FY 2004 as the effects of inspection program changes continued to be felt. Of the 30 issued during the year, 16 addressed stability program deficiencies, while equipment cleaning and QC unit problems appeared on half. Warning letters to foreign firms spiked to six from one the previous year. While Schering-Plough progresses in reinstating its compliance status following a 2002 consent decree, GlaxoSmithKline and Chiron take some enforcement heat. FDA field officials advise that openness during inspections can help their outcome. [The drug and therapeutic biologic cGMP warning letters issued in FY 2004 are listed. The listing is organized according to the type of facility involved and includes the recipient’s name, letter date, plant location, and a description of the problem areas cited.]

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