USFDA Form 483 Issued to Alkem Laboratories: Six Observations Noted at Chakan Unit

Alkem Laboratories faced a USFDA pre-approval inspection at its Chakan-based facility of Enzene Biosciences, resulting in a Form 483 with six observations. Notably, there were zero observations regarding data integrity. Alkem is preparing a response and has initiated corrective actions. Alkem shares rose by 1.37% on the BSE.

Alkem Laboratories announced that the US Food and Drug Administration (USFDA) has issued a Form 483 with six observations following an inspection of its Chakan manufacturing unit, operated by Enzene Biosciences, a subsidiary.

The USFDA inspection, completed on February 13, 2026, results in critical procedural observations, though none related to data integrity—an affirmation of Alkem's quality controls.

Enzene Biosciences is working on a response and implementing corrective and preventive measures. Alkem's stock gained 1.37% on the BSE, closing at Rs 5,475.55 per piece.

(With inputs from agencies.)