USFDA Completes Inspection of Enzene Chakan Unit

The US Food and Drug Administration (USFDA) has wrapped up its detailed review of the Enzene manufacturing unit in Chakan, Pune, marking a key milestone for the Indian biotech firm.

The Pre-Approval Inspection (PAI) was completed on February 13, 2026, at the facility operated by Enzene Biosciences, a subsidiary of Alkem Laboratories.

USFDA officials found six procedural observations during the inspection but, importantly, no issues tied to data integrity, signaling strong confidence in the company’s quality systems and regulatory record.

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After concluding the visit, the regulator issued a Form 483 outlining six procedural points that the company must address. This form is typically issued when inspectors observe conditions that could potentially violate standards under the Food, Drug, and Cosmetic Act. Despite these observations, Enzene’s achievement of zero data integrity findings stands out as a positive result, reinforcing that its data and documentation systems meet stringent international expectations.

Enzene is now working on a formal response to the USFDA within the required timeframe. Alongside this, the company has already begun implementing corrective and preventive actions to resolve the issues highlighted in the inspection report. Leadership at Enzene sees this as a step forward in their broader effort to meet global compliance and quality benchmarks.

For Alkem Laboratories, this inspection outcome underlines ongoing progress in strengthening its global regulatory footprint. The positive aspects of zero data integrity observations will be crucial as Enzene advances toward future approvals and potential market entries, especially in regulated markets like the United States.