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
- check out the report from the Boston Herald
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