Dr Reddy's Laboratories' wholly owned subsidiary Quimicas Falcon de Mexico Sa de C. V. at Cuernavaca, Mexico, engaged in chemical manufacturing has received a four item warning letter from the US FDA. The Mexico facility produces intermediates and APIs.
The US FDA inspected Mexico facility in November 2010. That inspection resulted in issuance of Form FDA 483, with observations. DRL responded to the 483 observations by implementing a number of corrective actions. However, the US FDA has asked for additional data and corrective actions to the items listed in the warning letter.
Dr Reddy's takes these matters seriously and will respond to the US FDA within the stipulated time frame. Dr Reddy's looks forward to working collaboratively with the US FDA to resolve the matters contained in the warning letter.