India, June 10 -- OneSource Specialty Pharma Limited , a leading contract development and manufacturing organization (CDMO) focused on specialty pharmaceuticals, announced that its flagship drug-device combination facility in Bangalore has received a "Voluntary Action Indicated" (VAI) classification from the U.S. Food and Drug Administration (USFDA), reaffirming its ongoing compliance with regulatory standards.
The classification follows a USFDA inspection conducted from March 20 to March 28, 2025, which concluded with the issuance of a Form 483 containing four observations. After a detailed and robust response from the company, the USFDA has officially closed the inspection, classifying the outcome as VAI.
Commenting on the development, ...