StockWatch
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Pharmaceuticals
USFDA30 Oct 2026, 02:09 pm

OneSource Pharma Gets USFDA EIR with VAI Classification

AI Summary

OneSource Specialty Pharma Limited has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Sterile Product Division (SPD) facility in Bengaluru. The facility received a 'Voluntary Action Indicated' (VAI) classification following an inspection conducted from June 22 to June 30, 2026. This outcome signifies the successful completion of the inspection process and reflects the company's commitment to high quality and regulatory compliance. The SPD facility is crucial for OneSource's sterile manufacturing capabilities and its role as a CDMO.

Key Highlights

  • USFDA inspection of Bengaluru SPD facility completed.
  • Facility received Voluntary Action Indicated (VAI) classification.
  • Report follows inspection conducted in June 2026.
  • Outcome reflects commitment to quality and regulatory compliance.