The US Food and Drug Administration (USFDA) has classified Zydus Lifesciences’ Jarod injectables manufacturing facility as ‘official action indicated’ (OAI), following an inspection. USFDA conducted inspection at the injectables manufacturing facility between April 15 and April 23, 2024.
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.