The US Food and Drug Administration (USFDA) recently issued four observations
following an inspection of Zydus Lifesciences' Moraiya manufacturing site in Ahmedabad, the company recently revealed.
The inspection took place from July 26 to August 5, 2022.
"We would like to let you know that from July 26 to August 5, 2022, the USFDA inspected our Moraiya manufacturing site in Ahmedabad.
Four Form 483 observations were made as a result of the inspection, the company reported in a BSE filing.
"No observations have any relevance to data integrity. Within the given timeframe, the business will handle the observations, said Zydus. ”
When an investigator(s) finds anything that, in their opinion, may be a violation of the Food, Drug, and Cosmetic (FD&C) Act and associated Acts,
they submit a USFDA Form 483 to the firm management at the end of the inspection.
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