Mumbai: US Food and Drug Administration (US FDA) has sent a warning letter to drug maker Dr Reddy’s Laboratories Ltd’s Mexican subsdiary—Industrias Quimicas Falcon de Mexico SA de C.V. on non-compliance of the regulator’s manufacturing quality norms. This facility produces intermediates and active pharmaceutical ingredients.
The FDA inspected Dr. Reddy’s facility in November 2010. This inspection resulted in issuance of a non-compliance letter, with several observations. Although DRL had responded to these observations by implementing a number of corrective actions, the US regulator has now asked for additional data and corrective actions.
DRL said on Tuesday in a release that it takes these matters seriously and will respond to the FDA within the stipulated timeframe. “Dr. Reddy’s looks forward to working collaboratively with the USFDA to resolve the matters contained in the warning letter,” it said.
C H Unnikrishnan