FDA Warns Claris Over Contaminated Drugs

Law360, New York (November 9, 2010, 5:05 PM EST) -- The U.S. Food and Drug Administration has formally warned India-based drugmaker Claris Lifesciences Ltd., a supplier to Pfizer Inc., about “significant violations” at its factory, including several batches of injectable drugs that were allegedly contaminated with fungus and bacteria.

The FDA publicly released a warning letter Tuesday revealing that Claris' factory in Ahmedabad, India, allegedly took a lax attitude to safety that allowed drugs intended for U.S. consumption to be contaminated.

Pfizer, for example, found in May that at least 31 bags of Claris-made metronidazole, an...
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