USFDA completes pre-approval inspection of manufacturing facility of Alkem Laboratories’ arm
At the conclusion of the inspection, the USFDA issued a Form 483 with 6 procedural observations
The United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) at the manufacturing facility of Enzene Biosciences (Enzene), a subsidiary of Alkem Laboratories.
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 Enzen’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.
Alkem Laboratories is among India’s leading global pharmaceutical companies. The company develops, manufactures and markets high-quality pharmaceutical products across all major therapeutic segments.
