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Dr. Reddy’s Gets FDA Warning Letter

Dr. Reddy’s chemical manufacturing facility in Cuernavaca, Mexico has received a four-item Warning Letter from the FDA.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Dr. Reddy’s chemical manufacturing facility in Cuernavaca, Mexico has received a four-item Warning Letter from the FDA. The FDA inspected the facility in November 2010, resulting in issuance of Form FDA 483 with observations. Dr. Reddy’s had responded to the 483 observations by implementing several corrective actions, but the FDA has asked for additional data and corrective actions to the items listed in the Warning Letter. Dr. Reddy’s plans to respond within the stipulated timeframe and will work with the FDA to resolve the matters. The Mexico facility produces intermediates and APIs.

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