Life Sciences

FDA warns Genzyme for GMP violations

Pharma Compliance Alert, March 18, 2009

Genzyme’s Allston, MA, facility significantly deviated from current Good Manufacturing Practices in the manufacture of licensed therapeutic drug products, bulk drug substances, and drug components, according to an FDA warning letter.

Genzyme sent two written responses to the FDA’s observation report, outlining planned corrective action. The FDA asked for addition details about the corrective actions in its warning letter, so it can evaluate whether the measures are adequate.

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