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FDA DRUG cGMP WARNING LETTERS

This article was originally published in The Gold Sheet

Executive Summary

...are showing the agency’s growing emphasis on the function of the quality unit as the key barometer of a firm’s compliance status. The focus on internal quality control oversight is built into FDA’s new systems-based inspection approach, which is currently being piloted in the drug area. The systems approach is intended to improve consistency in the field operations and optimize limited inspection resources, and may mean faster enforcement follow-up as well. The warning letter total and types of problems cited in FY 2000 are similar to the previous year. [The drug and therapeutic biologic cGMP warning letters issued in FY 2000 are listed on pp. 9-16. The listings include the recipient’s name, letter date, plant location, and a description of the problem areas cited.]
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