Zydus Lifesciences Ltd on Thursday said the US health regulator has classified as “official action indicated” for its injectables manufacturing facility at Jarod, near Vadodara in Gujarat, following an inspection. The US Food and Drug Administration (USFDA) conducted inspection at the injectables manufacturing facility between April 15 and April 23, 2024, Zydus Lifesciences said in a regulatory filing.
The company has received a report from the USFDA and it has determined that the inspection classification of this facility is ‘Official Action Indicated’ (OAI), it added.
As per the USFDA, OAI implies that the regulator may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non compliance of manufacturing norms laid down by it.
“The company will work closely with the agency to resolve the regulatory status of this facility expeditiously,” Zydus Lifesciences said.
