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news.Dr Reddy's Laboratories has received a warning letter from the US Food and Drug Administration (FDA) over its Mexico chemical facility - Industrias Quimicas Falcon de Mexico for violating the regulator’s manufacturing quality norms.
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Dr Reddy’s’ Mexico facility produces intermediates and active pharmaceutical ingredients (APIs).
The FDA issued Form FDA 483, with observations, following an inspection of the company’s facility in November 2010.
During the inspection the agency had identified deviations from current good manufacturing practice (cGMP) for the manufacture of APIs.
The pharma firm implemented a number of corrective actions and felt it has responded to the observations listed in the warning letter.
Later, the FDA has asked for additional data and corrective actions from the pharma firm.
The company said it will work on all the issues raised by the FDA to resolve matters included in the warning letter.