FY2017 GMP Drug Warning Letter Analysis

This article presents a detailed summary of the drug GMP warning letters issued in FY2017 as well as a comparison of trends since fiscal year 2013.  A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions including FDA forms-483, warning letters, seizures, recalls and consent decree agreements.  This allows manufacturers and sponsors to identify new trends and focus of FDA inspectors and act to address or justify similar situations at their own firms.

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