By: IPP Bureau
Last updated : December 24, 2023 8:25 am
This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 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.