Dr. Reddy’s Laboratories Ltd has announced that the import alert at Quimicas Falcon de Mexico SA de C.V. (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 United States Food and Drug Administration (USFDA) on 26 July, 2012.
Dr. Reddy’s Mexico facility was inspected by USFDA in November 2010. Based on observations by the USFDA, a Warning Letter was shared on June 14, 2011 with the company.
Dr. Reddy’s worked with USFDA 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.
The Mexico facility produces Intermediates and Active Pharmaceutical Ingredients