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Published on FiercePharma (http://www.fiercepharma.com)

FDA warns Genzyme on French plant

By admin
Created Oct 3 2007 - 6:59am

Clean up your act, Genzyme--or so says the FDA, which found "significant violations" of manufacturing rules at a French plant that produces the company's Thymoglobulin drug for kidney transplants.

Inspectors found higher-than-allowable levels of bacteria in some of the drug's components and concluded that the company didn't investigate those failures rigorously enough. Nor did the company thoroughly investigate the death of two animals during drug-safety tests. The company says it's heeding the FDA warning and already working to address the agency's concerns.

- read the FDA warning letter [1]
- check out the report [2] from the Boston Herald

Related Articles:
Boston officials herald big Genzyme expansion. Report [3]
Manufacturing woes plague launch of Myozyme. Report [4]
Genzyme reports successful late-stage stem cell study. Report [5]
Genzyme shifts focus after hylastan fails trial. Report [6]


Source URL:
http://www.fiercepharma.com/story/fda-warns-genzyme-french-plant/2007-10-03