USFDA issues 6 observations for Zydus Lifesciences Ahmedabad facility
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Ahmedabad: Zydus Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has closed the inspection with 6 observations at the Company's API site situated at Changodar, Ahmedabad.
This PAI-cum-GMP USFDA inspection was conducted from December 14 to December 22, 2023.
"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" the Company informed in a recent BSE filing.
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