USFDA completes inspection of Enzene's manufacturing unit at Chakan, Pune
At the conclusion of the inspection, the USFDA issued a Form 483 with 6 procedural observations. Enzene has achieved Zero observations related to data integrity - a critical validation of Enzene's quality systems and the reliability of regulatory filings.
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.
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