FDA 483 - Alkem Laboratories Limited - July 07, 2022

An FDA inspection of Alkem Laboratories Limited in Dhar, Madhya Pradesh, identified a critical issue with the firm's stability testing program. The company's accelerated stability studies and basic stability data are not adequately supported by ongoing full shelf-life studies. This deficiency results in unsupported tentative expiration dates for their drug products, including (b)(4) Tablets USP and (b)(4) Gel USP, evidenced by numerous out-of-specification results.