USFDA28 Jun 2025, 07:00 am
Granules India Ltd.: US FDA Completes Pre-Approval Inspection with One Observation at Granules Pharmaceuticals Subsidiary
AI Summary
Granules India Ltd. has announced that the US FDA has completed a Pre-Approval Inspection (PAI) at the facility of its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc., located in Chantilly, Virginia, USA. The inspection took place from 23rd June 2025 to 27th June 2025. A single 483 observation was issued during the inspection, which the subsidiary addressed and resolved during the inspection itself. This update is for the information and dissemination to the members of the exchange.
Key Highlights
- US FDA completed a Pre-Approval Inspection at Granules Pharmaceuticals, Inc.
- The inspection took place from 23rd June 2025 to 27th June 2025.
- A single 483 observation was issued during the inspection.
- Granules Pharmaceuticals, Inc. resolved the observation during the inspection.
- The update is intended for information and dissemination to the members of the exchange.