Dr Reddy's chemicals plant in Mexico receives USFDA warning
15 Jun 2011
The US Food and Drugs Administration (US FDA) has sent a fresh warning letter to Dr Reddy's Laboratories' (DRL) chemical manufacturing facility in Mexico over non-compliance of certain regulations.
Industrias Quimicas Falcon de Mexico SA de CV, a wholly owned chemicals manufacturing subsidiary of DRL, at Cuernavaca, Mexico, has received a "four-item warning letter" from the United States Food and Drug Administration (USFDA), DRL said in a release.
DRL said the USFDA had inspected its Mexico facility in November 2010, after which it issued a warning `Form FDA 483', with observations. The company had since implemented a number of corrective actions, it said.
However, the USFDA has asked for additional data and corrective actions to the items listed in the warning letter, DRL said.
DRL, however, did no give details on what data the US FDA had sought.
"Dr Reddy's takes these matters seriously and will respond to the USFDA within the stipulated timeframe. Dr Reddy's looks forward to working collaboratively with the USFDA to resolve the matters contained in the warning letter," the company said.
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