FDA Accuses Cadila Of Major Violations At India Plant

Law360, New York (July 6, 2011, 1:15 PM EDT) -- The U.S. Food and Drug Administration revealed Tuesday that it had warned drugmaker Cadila Healthcare Ltd. about significant manufacturing violations at a plant in India.

In a warning letter sent June 21 and published Tuesday, the FDA expressed concerns that Cadila's environmental monitoring program might not adequately detect all microbiological contaminants. The agency said it was dissatisfied with the corrective actions that Cadila had proposed following inspections earlier this year.

"Your firm has not established or followed appropriate written procedures designed to prevent microbiological contamination of...
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