“…we are pleased to inform that the company’s subsidiary Jubilant Cadista Pharmaceuticals Inc., USA, (Jubilant Cadista)’s solid oral formulations facility at Salisbury, Maryland, USA (Facility) has received the Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (USFDA) for the said Facility with respect to the inspection conducted by the said regulatory agency in January 2025,” Jubilant Pharmova said in a regulatory filing.
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The EIR follows an inspection conducted by the regulator in January 2025. With this, the inspection stands successfully closed. However, the facility is not expected to manufacture any products as its manufacturing operations were previously shut down, as disclosed by the company on April 18, 2024. Jubilant Cadista received the USFDA’s communication on March 11, 2025, at 09:27 PM IST.
What is Establishment Inspection Report (EIR)?
Based on the inspection and the response given by the company to the USFDA, the FDA will release an Establishment Inspection Report (EIR) within 30 days of the inspection. The EIR reflects the FDA’s official determination of a factory’s GMP compliance.
FDA and the Inspection Classification Database classify the inspection by each project area with one of three classifications. The three classifications displayed are: No Action Indicated (NAI), Voluntary Action Indicated (VAI) and Official Action Indicated (OAI).
What is Voluntary Action Indicated (VAI)?
Given when violations are found, but the problems do not justify further regulatory action. Improving GMP compliance is voluntary in this case. The facility can continue selling approved drugs and will also receive approvals of new filings.
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Shares of Jubilant Pharmova Ltd ended at ₹875.00, down by ₹16.55, or 1.86%, on the BSE.
