FDA inspects Zydus Biologics plant in Ahmedabad, notes 7 observations
Business
Zydus Biologics's injectable plant just had a GMP surveillance inspection by the US Food and Drug Administration at its injectable facility in Ahmedabad, running from April 27 to May 5, 2026.
The inspectors pointed out seven areas for improvement, but importantly, none were about data integrity, so no concerns about tampered records or missing information.
Zydus to address FDA observations quickly
On May 6, 2026, Zydus shared that it will closely work with the US Food and Drug Administration to sort out these observations quickly.