Zydus Biologics’ Ahmedabad injectable facility gets 7 observations in USFDA inspection
Zydus Lifesciences has made headlines as its Zydus Biologics injectable plant in Ahmedabad underwent a USFDA inspection between April 27 and May 5, 2026. The inspection yielded seven observations, but significantly, there were no issues regarding ...
By PTI |
New Delhi: Zydus Lifesciences Ltd on Wednesday said US health regulator has completed inspection at group firm Zydus Biologics' injectable plant at Ahmedabad with seven observations.
The US Food and Drug Administration (USFDA) conducted GMP surveillance inspection at Unit 9 facility located at Zydus Biotech Park, Changodar, Ahmedabad, Zydus Lifesciences said in a regulatory filing.
The inspection was conducted from April 27, 2026 to May 5, 2026, it added.
"The inspection closed with seven observations. There were no data integrity related observations," the filing said.
The company will closely work with the USFDA to address the observations expeditiously, it added.
The US Food and Drug Administration (USFDA) conducted GMP surveillance inspection at Unit 9 facility located at Zydus Biotech Park, Changodar, Ahmedabad, Zydus Lifesciences said in a regulatory filing.
The inspection was conducted from April 27, 2026 to May 5, 2026, it added.
"The inspection closed with seven observations. There were no data integrity related observations," the filing said.
The company will closely work with the USFDA to address the observations expeditiously, it added.
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