The United States Food and Drug Administration (USFDA) has conducted an inspection at the manufacturing facility SEZ-1 of Zydus Lifesciences located at Pharmez, Ahmedabad from March 20 to 24, 2023. The inspection was a Pre-Approval Inspection (PAI) as well as a GMP Audit and concluded with three observations. There were no Data Integrity related observations. The company is addressing these observations and will respond to them within the stipulated time.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.