Aavis Pharmaceuticals, part of Espee Group, located in Hoschton, GA, completed an inspection by the US Food and Drug Administration at the company's primary manufacturing facility with Zero 483 observations. With successful inspection of its formulation manufacturing plant Espee becomes the 3rd Group in Gujarat to have USFDA approved plant in USA.
The company's formulations facility was inspected by the USFDA for good manufacturing practices and PAI (Pre-Approval Inspection) in January 2019.
Aavis Pharma said it received the Establishment Inspection Report (EIR) in February 2019, which concludes the inspection process.