TITLE

GMP Warning Letters

AUTHOR(S)
Bush, Laura
PUB. DATE
October 2004
SOURCE
Pharmaceutical Technology;Oct2004, Vol. 28 Issue 10, p20
SOURCE TYPE
Trade Publication
DOC. TYPE
Article
ABSTRACT
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.
ACCESSION #
14734626

 

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