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USFDA Inspects Alkem Unit: 6 Observations Issued

16 Feb

Summary

Alkem's subsidiary manufacturing unit inspected by USFDA.
The inspection resulted in six procedural observations.
No data integrity issues were reported by the regulator.

USFDA Inspects Alkem Unit: 6 Observations Issued

Alkem Laboratories reported on February 16, 2026, that its subsidiary, Enzene Biosciences, located in Chakan, underwent a pre-approval inspection by the US Food and Drug Administration (USFDA). The inspection, which concluded on February 13, 2026, resulted in the issuance of a Form 483 detailing six procedural observations.

Significantly, the company highlighted that no observations related to data integrity were reported. This indicates a strong validation of Enzene's quality systems and the accuracy of its regulatory filings. Enzene Biosciences is currently formulating its comprehensive response to the USFDA, which will be submitted within the designated timeframe. The company has also initiated corrective and preventive actions to address the issued observations.

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