Dr Reddy's warned by US FDA over API facility in Mexico

Indian generic drug major Dr Reddy’s Laboratories (NYSE:RDY) revealed yesterday that its wholly-owned subsidiary Industrias Quimicas Falcon de Mexico has received a four item warning letter from the US Food and Drug Administration regarding its chemical manufacturing facility at Cuernavaca, which produces intermediates and active pharmaceutical ingredients.

The FDA inspected Dr Reddy’s Mexico facility in November 2010. That 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 FDA has asked for additional data and corrective actions to the items listed in the letter. Dr Reddy’s says it will respond to the USFDA within the stipulated timeframe to resolve the matters contained in the warning letter.

Deviations of cGPM regulations