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FDA DRUG GMP WARNING LETTERS

This article was originally published in The Gold Sheet

Executive Summary

...fell in half to 29 in FY 2003 from 58 the previous year, with the decline accelerating as the year progressed. Factors that may be at work include the new centralized clearance process at agency headquarters, the new quality systems inspection approach, and the diversion of FDA attention onto other high-risk enforcement concerns such as imported products. The dosage form receiving the most GMP warning letter attention was topicals, while the number of oral solid and repackager letters dropped sharply. Although limited in number this past year, the warning letters on sterile product operations contain detailed explanations of the agency’s key concerns in this area – contamination investigations, especially of metal particulates, was prominent among them. [The drug and therapeutic biologic cGMP warning letters issued in FY 2003 are included. 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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