Alkem Laboratories Ltd

Alkem's Enzene Biosciences Receives USFDA Inspection Results 🧪

- USFDA completed a Pre-Approval Inspection (PAI) at Enzene Biosciences Limited, a subsidiary of Alkem Laboratories.

- USFDA issued a Form 483 with 6 procedural observations.

- Zero observations related to data integrity, validating Enzene's quality systems and regulatory filing reliability.

- Enzene is preparing a response to USFDA and has initiated corrective and preventive actions.