The USFDA concluded a pre-approval inspection of Zydus Lifesciences’ oncology injectable manufacturing facility in Ahmedabad on November 13, 2025. The inspection, which related to the new isolator injectable line, resulted in two observations. Importantly, there were no observations related to data integrity. Zydus will work with the USFDA to address the findings promptly.
USFDA Inspection Concludes
Zydus Lifesciences announced the completion of a pre-approval inspection by the USFDA at its oncology injectable manufacturing facility located in SEZ1, Ahmedabad. The inspection concluded on November 13, 2025.
Key Details of the Inspection
The inspection was focused on the new isolator injectable line at the facility. According to the company’s announcement, the USFDA issued two observations at the close of the inspection. Notably, there were no observations regarding data integrity.
Next Steps
Zydus Lifesciences has stated its commitment to working closely with the USFDA to address the observations quickly. The company aims to resolve the issues and maintain compliance with USFDA standards.
Source: BSE
