What happened during the USFDA inspection at Alkem's subsidiary?

The USFDA inspected Enzene Biosciences' manufacturing unit in Chakan, issuing a Form 483 with six procedural observations.

Were there any data integrity issues at Enzene Biosciences?

No, Alkem Laboratories stated that zero observations related to data integrity were issued by the USFDA.

Form 483 is issued by the USFDA to a firm's management when an inspection reveals conditions that may violate the Food, Drug and Cosmetic Act.

Home / Health / USFDA Inspects Alkem Unit: 6 Observations Issued

USFDA Inspects Alkem Unit: 6 Observations Issued

16 Feb

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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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