DR Reddy’s Laboratories Limited on Wednesday said its chemical manufacturing facility at Cuernavaca, Mexico, has received a four-item warning letter from the United States Food and Drug Administration (US FDA). The facility, its wholly-owned subsidiary, produces intermediates and active pharmaceutical ingredients (bulk drugs).
The warning letter comes even as Dr Reddy's responded to the observations made by the US FDA after inspecting the facility in November, 2010, by implementing a number of corrective actions, according to a company release.
Dr Reddy’s said it responded to the 483 observations by implementing a number of corrective actions.
The US FDA had asked for additional data and corrective actions to the items listed in the warning letter, the company said while stating it would take these matters seriously and respond to the US drug regulator within the stipulated time fame.
“Dr Reddy’s looks forward to working collaboratively with the US FDA to resolve the matters contained in the warning letter,” the company said.