Alkem Labs Plant in India Cited Over OOS Investigations, Quality Systems

FDA issued a 26-page Form 483 to Alkem Laboratories following an 4/20-5/1 inspection of the company's finished drug manufacturing facility in Daman, India, citing significant quality system deficiencies, including failures to adequately investigate out-of-specification (OOS) and out-of-trend (OOT) test results.

According to the inspection report, FDA investigators found the company's investigations into OOS and OOT results were not sufficiently thorough and that corrective and preventive actions were inadequate to assess potential risks to drug products distributed in the U.S. The agency cited examples involving stability testing in which an unidentified impurity produced confirmed OOS results, yet an affected batch was not recalled from the U.S. market after the initial six-month stability failure and subsequently failed again at the 12-month stability time point.