Pharmaceutical company Alkem Laboratories is facing regulatory scrutiny from the United States Food and Drug Administration (USFDA) following inspectional observations at its manufacturing facility in Amaliya, Daman. The inspection, conducted over 12 days from April 20 to May 1, resulted in the issuance of a Form 483 with seven flagged observations. A Form 483 is issued when potential violations of the Food, Drug, and Cosmetic Act are identified, particularly related to manufacturing practices and product safety.
Alkem Laboratories has acknowledged receiving the observations but has not disclosed specific details about the raised issues. The company has committed to addressing all seven observations within the required timeline. The regulatory development was officially reported to the BSE Limited and the National Stock Exchange of India on May 2, 2026, to comply with disclosure regulations.
In a recent positive regulatory update for Alkem Laboratories, its Daman facility received a Good Manufacturing Practice (GMP) compliance certificate from the Malta Medicines Authority in March. This certification, valid for three years, confirms that the facility meets European Union GMP standards. The scrutiny on Alkem Laboratories comes shortly after the USFDA issued a Form 483 with three observations to another drug maker, Lupin, following an inspection conducted between April 13 and April 17.
