Dr Reddy’s Laboratories’ Mexican arm -- Industrias Quimicas Falcon de Mexico SA -- has received a warning letter from US Food and Drug Administration (USFDA) for violation of current goods manufacturing practice regulations. The company's Mexico facility produces intermediates and active pharmaceutical ingredients.
The USFDA had inspected the company’s Mexico facility in November 2010 and later sought certain explanations from the company. However, the regulator issued the warning letter dated June 3, citing 'lack of corrective actions' by the firm. Dr Reddy’s felt it responded to the 483 observations by implementing a number of corrective actions. However, the USFDA has asked for additional data and corrective actions to the items listed in the warning letter.
The company looks forward to working collaboratively with the USFDA to resolve the matters contained in the warning letter.
