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FDA compliance office analyzing inspection and enforcement data to detect trends.

This article was originally published in The Tan Sheet

Executive Summary

FDA COMPLIANCE OFFICE ANALYZING INSPECTION AND ENFORCEMENT DATA to get a clearer picture of current trends and compliance trouble spots, FDA Division of Manufacturing & Product Quality Director Douglas Ellsworth explained at the National Association of Pharmaceutical Manufacturers annual meeting in Naples, Fla. on Jan 31. The analysis has not been completed for 1996, but Ellsworth said preliminary review of the data indicates that the GMP trouble spots "remain pretty much what they have been for some time": lab operations, validation issues and "in some areas of the bulk industry, adequate contamination control."
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