Alkem Labs' Chakan facility gets six observations in USFDA inspection, no data integrity issues

New Delhi: Alkem Laboratories on Monday said the US health regulator has issued a Form 483 with six observations after inspecting the Chakan-based manufacturing unit of its wholly-owned subsidiary.

The US Food and Drug Administration (USFDA) completed a pre-approval inspection on February 13, 2026 at the manufacturing facility of Enzene Biosciences, the drug firm said in a regulatory filing.

"At the conclusion of the inspection, the USFDA issued a Form 483 with 6 procedural observations," it added.


The company has achieved zero observations related to data integrity, a critical validation of its quality systems and the reliability of regulatory filings, Alkem stated.

Enzene is in the process of preparing and submitting its response to the USFDA within the stipulated timeline and has initiated appropriate corrective and preventive actions, it added.

As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection, when the investigator has observed any conditions that may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts.

Alkem Labs shares on Monday ended 1.37 per cent up at Rs 5,475.55 apiece on BSE.