Alkem Laboratories Gets USFDA Form 483 With 7 Observations At Daman Facility

Pharmaceutical major Alkem Laboratories has come under regulatory scrutiny after the United States Food and Drug Administration issued seven observations at its manufacturing facility in Amaliya, Daman.

The inspection, conducted over 12 days from April 20 to May 1, concluded with the issuance of a Form 483, officially known as a Notice of Inspectional Observations.

This document is issued when investigators identify conditions that may potentially violate provisions of the Food, Drug and Cosmetic Act, particularly those related to manufacturing practices, quality systems, or product safety.

The company acknowledged receipt of the observations but did not disclose specific details. It stated that it would respond to all seven observations within the stipulated timeline.

The company disclosed the development to BSE Limited and the National Stock Exchange of India on May 2, 2026, in compliance with regulatory norms.

The regulatory action comes shortly after a positive development for Alkem Laboratories.

In March, the company announced that its Daman facility had received a Good Manufacturing Practice compliance certificate from the Malta Medicines Authority.

The certification followed an inspection conducted on December 9, 2025, confirming adherence to European Union GMP standards, and is valid for three years.

In a separate development within the pharmaceutical sector, Lupin recently received three observations from the USFDA following an inspection conducted between April 13 and April 17, as disclosed in a regulatory filing.