
USFDA3 Jun 2026, 11:50 am
Granules Pharma gets USFDA EIR for Chantilly facility
AI Summary
Granules India Limited announced that its wholly-owned subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received the Establishment Inspection Report (EIR) from the US FDA for its Chantilly, Virginia facility. The facility received a Voluntary Action Indicated (VAI) classification following an inspection conducted from March 30 to April 3, 2026, where four Form 483 observations were issued. This facility is crucial to Granules' global manufacturing and supply network, with a focus on quality and regulatory compliance.
Key Highlights
- USFDA issued EIR for Granules Pharma's Chantilly facility.
- Facility classified as Voluntary Action Indicated (VAI).
- Inspection conducted March 30 - April 3, 2026.
- Four Form 483 observations were issued during the inspection.
Price Impact
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