Zydus Lifesciences Ltd. (formerly Cadila Healthcare Ltd.), a global lifesciences company, has announced that the United States Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) for its Jarod injectables manufacturing facility near Vadodara, India. The establishment inspection report denotes the completion of the inspection.
The USFDA inspected the facility from February 24th to March 10th, 2022.
According to Zydus, the USFDA determined that the facility’s inspection classification is Voluntary Action Indicated (VAI) and that the inspection is considered “closed” under 21 CFR 20.64(d) (3). The inspection covered 15 ANDAs and was a Pre-Approval cum cGMP inspection.
An objectionable condition or practise has been discovered, but the agency is not prepared to take or recommend any administrative or regulatory action.
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