Alkem Laboratories has informed the National Stock Exchange of India (NSE India) that the US Food and Drug Administration (US FDA) conducted an inspection at the company’s manufacturing facility located at Amaliya, Daman, from April 20 to May 1, 2026.

Following the conclusion of the inspection, the company received a Form 483 with seven observations from the US regulatory authority.

In its regulatory filing to the NSE, Alkem Laboratories stated that it will address the observations raised by the US FDA within the stipulated timeline.

Form 483 is issued by the US FDA at the conclusion of an inspection when investigators identify conditions that may require corrective action or procedural improvements at a manufacturing facility.