Granules India’s arm receives four observations from USFDA
The observations are related to procedural matters and no data integrity - related observations
Granules India’s wholly-owned subsidiary -- Granules Pharmaceuticals, Inc. (GPI), located in Chantilly, Virginia, US, has completed a routine current Good Manufacturing Practices (cGMP) audit by the US Food and Drug Administration (FDA) with four Form 483 observations. This inspection was conducted from March 30 to April 3, 2026 and marks the second USFDA inspection at the Chantilly facility in last one year. The observations are related to procedural matters and no data integrity - related observations were reported during the inspection.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
