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US FDA classifies Jubilant Spokane plant as VAI
The Hindu BusinessLine··12 Sept
Jubilant Pharmova said the U.S. FDA classified its Jubilant HollisterStier Spokane contract manufacturing site as Voluntary Action Indicated after a June inspection. The agency reviewed the Establishment Inspection Report for the visit from June 8 to June 17, 2026, the filing said. VAI means objectionable conditions were found but the FDA does not intend to recommend administrative action.
Prism
What It Means For You
- Drug sponsors using the Spokane site may audit corrective actions before releasing batches.
- VAI classifications still require voluntary fixes to practices flagged by inspectors.
- Contract manufacturers often brief clients after FDA classification letters.
What's Happening
- Jubilant HollisterStier is a step-down subsidiary under Jubilant Pharmova.
- The Spokane facility performs contract manufacturing for pharmaceutical clients.
- FDA concluded its EIR review before issuing the VAI label Friday.
Spokane CMO inspection
- Voluntary Action Indicated is one FDA outcome short of official enforcement.
- Establishment Inspection Reports summarize findings from plant visits.
- Jubilant Pharma Holding sits between the U.S. unit and Singapore parent.
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