Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod

The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs

Zydus Lifesciences announced that it 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.

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. The USFDA had inspected the facility from 24th February to 10th March, 2022.