New Delhi, Mar 10:
Zydus Lifesciences on Thursday said the US health regulator has issued three observations after inspecting its Jarod (Vadodara) based manufacturing facility.
The US Food and Drug Administration (USFDA) inspected the injectable facility from February 24 to March 10, 2022.
The inspection closed with three observations, the drug firm said in a regulatory filing.
“We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture across our entire manufacturing network, and are committed to remain compliant with high standards of good manufacturing practices across our network,” Zydus Lifesciences stated.
As per the US health regulator, an FDA Form 483 (observation) is issued to a firm’s management at the conclusion of an inspection when investigators have observed any conditions that in their judgment may constitute violations of Food Drug and Cosmetic (FD&C) Act and related Act. (PTI)
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