FDA’s Blizzard of Enforcement at Compounding Pharmacies Evident in GMP Warning Letters for FY 2014 By Joanne S. Eglovitch

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

By Joanne S. Eglovitch / Email the Author / View Full Issue
Word Count: 5820 / Article # 08150226004 / Posted: February 26 2015 5:55 PM

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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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