US FDA lifts import alert from Dr. Reddy’s Mexican chemical manufacturing facility
30 Jul 2012
Hyderabad-based Dr. Reddy's Laboratories Ltd has announced that the import alert at Dr. Reddy's Mexican chemical manufacturing facility at Cuernavaca, Quimicas Falcon de Mexico SA de C.V, a wholly owned subsidiary of Dr. Reddy's Laboratories Limited has been lifted.
Quimicas Falcon de Mexico makes intermediates and active pharmaceutical ingredients.
Dr. Reddy's received a clearance from the United States Food and Drug Administration (USFDA) to this effect last week.
In July 2011, the US FDA had imposed an import ban on products made at Dr Reddy's Laboratories' Mexico unit for violation of manufacturing practice rules after it issued a four-item warning in June, based on an inspection in November 2010. (See: US FDA slaps ban on Dr Reddy's Mexico products)
"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," Dr Reddy's said in a statement.
With the 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.