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Glenmark's Goa Facility Cleared by US FDA with VAI Status
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News18•23-09-2026, 10:00
Glenmark's Goa Facility Cleared by US FDA with VAI Status
- •Glenmark Pharmaceuticals received an Establishment Inspection Report (EIR) from the US FDA for its Goa formulations manufacturing facility.
- •The inspection concluded with a Voluntary Action Indicated (VAI) status, meaning no regulatory action is recommended, but the company should take corrective measures.
- •The US FDA conducted the inspection at the Goa facility from June 22 to June 30.
- •Glenmark Pharmaceuticals operates 11 manufacturing facilities globally and has a commercial presence in over 80 countries.
Key Questions Answered
A Voluntary Action Indicated (VAI) status means that although objectionable conditions were observed during the inspection, the US health regulator does not recommend any formal regulatory action and expects the company to take voluntary corrective measures.
The US health regulator conducted the inspection at Glenmark's Goa formulations manufacturing facility from June 22 to June 30.
Following the Good Manufacturing Practices inspection conducted between June 22 and June 30, 2026, the US FDA issued a Form 483 carrying six observations to Glenmark Pharmaceuticals.
