Dr. Reddys chemical manufacturing facility at Cuernavaca, Mexico receives warning letter

Dr. Reddys Laboratories has announced that Industrias Quimicas Falcon de Mexico SA de C.V. (Dr. Reddys chemical manufacturing facility at Cuernavaca, Mexico), a wholly owned subsidiary of Dr. Reddys Laboratories has received a four item warning letter from the United States Food and Drug Administration (USFDA).

The USFDA inspected Dr. Reddys Mexico facility in November 2010. That Inspection resulted in issuance of Form FDA 483, with observations. Dr. Reddys 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. Dr. Reddys takes these matters seriously and will respond to the USFDA within the stipulated timeframe. Dr. Reddys looks forward to working collaboratively with the USFDA to resolve the matters contained in the warning letter. The Mexico facility produces intermediates and active pharmaceutical ingredients.

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