GMP Warning Letters

Bush, Laura
October 2004
Pharmaceutical Technology;Oct2004, Vol. 28 Issue 10, p20
Trade Publication
The article reports that the U.S. Food and Drug Administration issued two warning letters in August 2004 concerning violations of good manufacturing practices (GMP). On August 3, 2004 the Center for Drug Evaluation and Research sent a warning letter to Bioren SA, a subsidiary of generics oncology manufacturer Bigmar Inc., for GMP violations at its facility in Barbengo, Switzerland. The Center for Biologics Evaluation and Research sent the second August warning letter to Aventis-Pasteur SA.


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