US FDA lifts import alert Dr Reddy’s Mexico facility

US FDA lifts import alert on Dr Reddy’s Mexico facility

10:57 AM, 30th July 2012
US FDA lifts import alert on Dr Reddy’s Mexico facility

HYDERABAD, INDIA: Dr Reddy’s Laboratories announced that the import alert at Quimicas Falcon de Mexico SA de CV (Dr Reddy’s chemical manufacturing facility at Cuernavaca, Mexico), a wholly owned subsidiary of Dr Reddy’s Laboratories Limited has been lifted. Dr Reddy’s received a clearance from the US Food and Drug Administration (FDA) on 26 July 2012.

Dr Reddy’s Mexico facility was inspected by US FDA in November 2010. Based on observations by the US FDA, a warning letter was shared on 14 June 2011 with the company. Dr Reddy’s worked with US FDA to resolve the observations in the warning letter. An inspection report after the last inspection from 26 – 30 March 2012 indicated that they are satisfied with all the outstanding action points that Dr Reddy’s has submitted. With the satisfactory closure of observations in the warning letter and the lifting of the import alert, Dr Reddy’s can now start importing products to the US from this facility.

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