Friday, February 27, 2015

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


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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