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BioPharmaceutical Asia Pacific Australia

FDA’s Blizzard of Enforcement at Compounding Pharmacies Evident in GMP Warning Letters for FY 2014

This article was originally published in The Gold Sheet

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Executive Summary

Inadequate control of contamination – in people, processes and places – was the dominant problem found in the 45 drug GMP warning letters that FDA issued in FY 2014. More than half went to compounding pharmacies.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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