USFDA classifies OneSource Bangalore drug-device combination facility as VAI
Bangalore: OneSource Specialty Pharma Limited, a multi-modality specialty pharma pure-play CDMO, has announced that its flagship facility in Bangalore, India, has received a "Voluntary Action Indicated" (VAI) classification from the U.S. Food and Drug Administration (USFDA), confirming its continued compliance.
Following an inspection of the company's flagship facility from March 20 to March 28, 2025, the USFDA issued a Form 483 with four observations.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Based on the company's comprehensive response and commitments, the agency has classified the inspection outcome as Voluntary Action Indicated (VAI), officially closing the inspection.
VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
Neeraj Sharma, Managing Director & CEO, said, " 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.”
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