US FDA has recently lifted import alert at Quimicas Falcon de Mexico SA de CV, Dr Reddy’s chemical manufacturing facility at Cuernavaca, Mexico. The facility, a wholly-owned subsidiary of Dr Reddy’s Laboratories (DRL), was inspected by US FDA in November 2010. Based on observations by the US FDA, a warning letter was shared on June 14, 2011 with the company.
DRL worked with US FDA to resolve the observations in the warning letter. An inspection report after the last inspection from March 26-30, 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, DRL can now start importing products to the US from this facility. The Mexico facility produces Intermediates and Active Pharmaceutical Ingredients.
EP News Bureau