Zydus Biologics Receives USFDA Observations
Zydus Lifesciences Ltd announced that the USFDA concluded an inspection at Zydus Biologics' injectable plant in Ahmedabad, resulting in seven observations. The inspection, part of GMP surveillance at the Changodar facility, found no data integrity issues. Zydus will work closely with USFDA to address these observations promptly.
Zydus Lifesciences Ltd revealed on Wednesday that the US Food and Drug Administration (USFDA) had completed an inspection at its Zydus Biologics plant in Ahmedabad, resulting in seven observations.
The government agency conducted a Good Manufacturing Practice (GMP) surveillance inspection at the Unit 9 facility, located at Zydus Biotech Park in Changodar, Ahmedabad. This inspection took place over several days, from April 27 to May 5, 2026.
While the inspection concluded with seven observations, Zydus Lifesciences was quick to point out there were no issues related to data integrity. The company has committed to working closely with the USFDA to resolve the concerns promptly.
(With inputs from agencies.)
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