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FY 2015 Drug GMP Warning Letters Hit Compounders and Foreign Sites

This article was originally published in The Gold Sheet

Executive Summary

FDA issued 42 GMP drug warning letters in FY 2015, a 6% reduction compared to the previous year. The agency’s enforcement efforts continue to focus on compounding pharmacies and foreign manufacturing sites, while data integrity lapses continue to grow and a UK MHRA inspector said that a different mindset is needed to resolve these problems.

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