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DRUG GMP WARNING LETTERS

This article was originally published in The Gold Sheet

Executive Summary

...are now being cleared by CDER's compliance office to help ensure their consistency and effectiveness, as FDA's "GMPs for the 21st Century" initiative marches forward. The agency also has made progress under the initiative in: -- developing a dispute resolution system for GMP issues -- clarifying FDA-483 language -- creating specialized drug inspection teams, and -- revising the enforcement approach to Part 11. In FDA's 2002 fiscal year, the downtrend in drug GMP warning letters continued, with 58 firms on the receiving end. Only one foreign manufacturer received a warning letter, and the number issued to API firms dropped dramatically from the previous year. [The drug and therapeutic biologic cGMP warning letters issued in FY 2002 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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