USFDA issues 1 observation for Granules Pharma USA facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-06-28 05:46 GMT | Update On 2025-06-28 05:46 GMT
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Hyderabad: Granules India has announced that the U.S. Food and Drug Administration (US FDA) has issued one 483 observation after a Pre-Approval Inspection (PAI) for a first to file controlled substance ANDA at the facility of Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA.
The facility was inspected from 23rd June 2025 to 27th June 2025.
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