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FDA cGMP WARNING LETTERS

This article was originally published in The Gold Sheet

Executive Summary

...issued to foreign drug manufacturers in FY 1997 dropped by two-thirds from the previous year. The inspection performance declined for domestic firms, which received 50% more agency warnings than in FY 1996. Warning letters to oral solid manufacturers correspond with recall actions during FY 1997. Failure investigations, stability programs, and process validation remain key FDA compliance concerns. HPLC testing and labeling/ packaging procedures are also on the agency’s radar screen. [The drug cGMP warning letters issued in FY 1997 are listed on pp. 8-16. The listing includes the recipient's name, letter date, plant location and a description of the problem areas cited.
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