Dr Reddy’s Mexico facility receives warning letter from US FDA

Dr Reddy’s Mexico facility receives warning letter from US FDA

5:17 PM, 17th June 2011
Dr Reddy’s Mexico facility receives warning letter from US FDA

 

HYDERABAD, INDIA: Dr Reddy’s Laboratories Ltd said that Industrias Quimicas Falcon de Mexico SA de C V (Dr Reddy’s chemical manufacturing facility at Cuernavaca, Mexico), its wholly owned subsidiary received a four item warning letter from the US Food and Drug Administration (USFDA). The Mexico facility produces intermediates and active pharmaceutical ingredients.

The USFDA inspected Dr Reddy’s Mexico facility in November 2010. The inspection resulted in issuance of Form FDA 483, with observations. Dr Reddy’s felt it responded to the 483 observations by implementing a number of corrective actions. However, the USFDA has asked for additional data and corrective actions to the items listed in the warning letter. Dr Reddy’s takes such matters seriously, will respond to the USFDA within stipulated timeframe.

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