Zydus Receives USFDA EIR with VAI Status for Ahmedabad Injectable Facility
New Delhi: Zydus Lifesciences Limited has announced that it has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its injectable manufacturing facility located at Zydus Biotech Park, Ahmedabad.
In a regulatory filing, the company said the USFDA classified the facility as Voluntary Action Indicated (VAI) following a Good Manufacturing Practices (GMP) surveillance inspection conducted between April 27 and May 5, 2026.
The receipt of the EIR signifies the conclusion of the inspection process for the facility. Under a VAI classification, the USFDA concludes that while objectionable conditions were observed during the inspection, they do not warrant regulatory or enforcement action.
The company disclosed the development under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. No additional details regarding the inspection observations were disclosed by the company.
