Zydus Lifesciences' API site in Ahmedabad. receives 6 observations from USFDA
Drug Approval

Zydus Lifesciences' API site in Ahmedabad. receives 6 observations from USFDA

This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023

  • By IPP Bureau | December 23, 2023

Zydus Lifesciences Ltd has announced that the USFDA conducted an inspection at the API site situated at Changodar, Ahmedabad.

This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023.

The inspection closed with 6 observations. There were no Data Integrity related observations. There are no repeat observations from the previous inspection.

There are 4 DMFs of this site under approval with the USFDA. The Company will closely work with the USFDA to address the observations.

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