Rx REPORT

An Analysis of FDA FY2016 Drug GMP Warning Letters

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Barb Unger, of Unger Consulting Inc., has written a superb article that makes sense of all the complicated and obscure statistics that FDA issues regarding warning letters and import alerts on GMP drug warning letters.

Barb has lead the Rx-360 Monitoring and Reporting group from 2009 until November 2014 when she left Amgen.  She is now the co-lead of Rx-360’s Data Integrity group with Elayne Best of Biogen.

This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Firms should monitor publicly available health authority enforcement actions and trends as part of a comprehensive GMP intelligence program, because FDA expects firms to monitor these actions and to correct similar deficiencies at their site(s).

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