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USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI
Drug Approval | February 17, 2026

USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI

The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.