USFDA issues 3 observations for Zydus Lifesciences Ahmedabad facility
The inspection was a Pre-Approval Inspection as well as a GMP Audit.;
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Ahmedabad: Drug major, Zydus Lifesciences, has recently announced that the US Food and Drug Administration (USFDA) has concluded an inspection with three observations at the company's manufacturing facility SEZ-1 located at Pharmez, Ahmedabad.
The inspection was held from March 20 to 24, 2023.
"The inspection was a Pre-Approval Inspection (PAI) as well as a GMP Audit and concluded with three observations. There were no Data Integrity related observations," the company said in a BSE filing.
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