Home / Business and Economy / USFDA Inspects Alkem Daman Plant, Issues Observations
USFDA Inspects Alkem Daman Plant, Issues Observations
2 May
Summary
- USFDA issued Form 483 observations at Alkem's Daman facility.
- Inspection occurred between April 20 and May 1, 2026.
- Alkem committed to addressing all seven observations timely.
Alkem Laboratories Limited is currently under scrutiny by the United States Food and Drug Administration (USFDA). The regulatory body conducted an inspection of the company's manufacturing facility in Amaliya, Daman, over a 12-day period. This inspection concluded on May 1, 2026, resulting in the issuance of a Form 483, which details inspectional observations.
The USFDA's Form 483 identifies conditions that may indicate violations of the FD&C Act. In this instance, seven observations were noted at Alkem's Daman facility. The company has formally acknowledged receipt of these observations and has assured that all seven points will be addressed within the designated timeframe.
Alkem Laboratories disclosed this regulatory update to the BSE Limited and National Stock Exchange of India Limited on May 2, 2026. This inspection comes after the same Daman facility received a Certificate of GMP Compliance from the Malta Medicines Authority in March 2026, valid for three years.
