Zydus Lifesciences gets EIR from USFDA for Jarod facility
The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs.
Ahmedabad: Zydus Lifesciences Ltd. (formerly known as Cadila Healthcare Ltd.), a global lifesciences company has announced that the company has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Jarod injectables manufacturing facility near Vadodara, India. Establishment Inspection Report means the closure of inspection.
The USFDA had inspected the facility from 24th February to 10th March, 2022.
Zydus said that the USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI) and has concluded that the inspection is considered as "closed" under 21 CFR 20.64(d)(3). The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs.
Voluntary Action Indicated (VAI) means objectionable conditions or practices that were found but the agency is not prepared to take or recommend any administrative or regulatory action.
Read also: Zydus Lifesciences Chemotherapy drug Pemetrexed gets USFDA okay
Medical Dialogues team had earlier reported that Zydus Lifesciences had received three observations from the US health regulator after inspection of its Jarod (Vadodara) based manufacturing facility.
Read also: USFDA issues 3 observations for Zydus Lifesciences's Vadodara plant
