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.
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