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Sterility Testing, Contamination Concerns Lead to Warning Letter for Teva Pharmaceuticals

Nov. 1, 2016

Teva Pharmaceuticals has received a warning letter due to sterility testing and contamination issues at its plant in Godollo, Hungary.

The letter, issued in October, cited Teva for failing to thoroughly investigate media fill contamination and sterility test failures.

Teva also did not thoroughly investigate sterility test positives, and the investigation of those test positives did not adequately assess the hazards in the aseptic manufacturing operation that led to sterility failures. Teva did investigate why a test yielded 31 contaminated units, but the FDA said it was insufficient as Teva failed to identify the microorganisms in the contaminated units.

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