US FDA finds violations at Alkem Labs’ Daman facility after 12-day inspection

Pharmaceutical major Alkem Laboratories Limited has come under regulatory scrutiny after the United States Food and Drug Administration (USFDA) issued inspectional observations at its manufacturing facility in Amaliya, Daman, following a recent inspection.

The inspection, carried out over a 12-day period from April 20 to May 1, concluded with the issuance of Form 483 by FDA, citing seven observations.

An FDA Form 483, formally known as the ‘Notice of Inspectional Observations,’ is issued to a company’s management at the end of an inspection when investigators identify conditions that may represent violations of the Food, Drug and Cosmetic (FD&C) Act regulations. The document highlights compliance concerns related to manufacturing practices, quality systems or product safety.

Following the completion of the inspection, the company has acknowledged receipt of the observations and stated that it will address all seven points raised by the regulator within the stipulated timeframe.

But Alkem Laboratories did not provide specific details regarding the nature of the observations.

The company formally disclosed the update to Indian stock exchanges, BSE Limited and National Stock Exchange of India Limited, as part of its mandatory regulatory compliance obligations on May 2, 2026.

The development follows the company’s announcement in March that its manufacturing facility in Daman, India, had received a Certificate of GMP Compliance from the Malta Medicines Authority. The certificate was issued after an inspection conducted on December 9, 2025. It remains valid for three years. It confirms compliance with European Union Good Manufacturing Practices (EU GMP) standards.

The approval was granted after an earlier inspection by the Malta Medicines Authority as disclosed by Alkem Laboratories on December 10 last year.