OneSource Specialty Pharma Limited, a contract development and manufacturing organization (CDMO) specializing in multi-modality pharmaceutical solutions, has announced that its flagship facility in Bangalore has received a “Voluntary Action Indicated” (VAI) classification from the U.S. Food and Drug Administration (USFDA).
The classification follows a scheduled USFDA inspection conducted from March 20 to March 28, 2025. At the conclusion of the inspection, the agency issued a Form 483 listing four observations. The company submitted a detailed response addressing each observation.
After reviewing the company’s response and corrective action commitments, the USFDA designated the inspection outcome as VAI. This indicates that while the agency identified issues during the inspection, the violations were not deemed significant enough to warrant regulatory or enforcement action. The VAI classification also confirms that the inspection has been officially closed by the USFDA.
The facility plays a central role in OneSource’s manufacturing and development operations. The company has not disclosed the specific nature of the observations listed in the Form 483.
Neeraj Sharma, Managing Director & CEO, stated,” The successful closure of our latest USFDA inspection is a pivotal moment in our journey, and we are very pleased with this outcome demonstrating our exemplary compliance status. Our flagship facility, Unit 2, is the cornerstone of our manufacturing capabilities in Drug Device Combinations (DDC), biologics drug substances, and complex injectables. This milestone validates our deep-rooted commitment to quality and is crucial as our partners prepare to launch key GLP-1 products in late FY26. We are excited to advance into our next significant commercial phase.”
