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, Neeraj Sharma, Managing Director & CEO, stated, “The successful conclusion of our most recent USFDA inspection marks a significant milestone in our journey. We are extremely pleased with this outcome, which reflects our strong compliance track record. Our Bangalore-based Unit 2 facility serves as the backbone of our manufacturing operations for Drug-Device Combinations (DDC), biologics drug substances, and complex injectables. This achievement reinforces our unwavering commitment to quality and comes at a critical time as our partners gear up to launch key GLP-1 products in late FY26. We look forward to entering our next major phase of commercial growth.”