FDA Lifts Import Alert, Sends Closeout Letter to Dr. Reddy’s Mexico API Plant

Dr. Reddy’s can once again export products from its Morelos, Mexico, manufacturing facility to the U.S. thanks to an FDA closeout letter and the removal of an import alert that stemmed from an unfavorable agency inspection more than a year ago. The Indian generic-drug and active pharmaceutical ingredient maker has addressed the GMP issues highlighted in a June 3, 2011, warning letter, according to the July 12 closeout letter posted online late last month.
Drug GMP Report