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Contamination and Raw Material Testing Issues Raised in FDA Warning Letters

This article was originally published in The Gold Sheet

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Executive Summary

FDA investigators are continuing to find contamination problems and inadequate testing, according to 20 warning letters issued in the first half of 2013, as well as a troubling trend of repeat observations at Baxter, Hospira and Apotex. Observers say to expect more sterility concerns in future warning letters, particularly involving mold, as FDA ramps up GMP enforcement at 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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