Contamination and Raw Material Testing Issues Raised in FDA Warning Letters

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.

Inadequate control of contamination continues to be a common problem found in drug GMP warning letters, while insufficient raw material testing is a growing problem seen in the 20 drug GMP warning letters FDA issued in the first half of 2013.

Observers also say to expect more sterility problems, such as mold, as FDA ramps up its GMP enforcement of compounding...

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