ScoutQuest30 Oct 2026
Onesource Specialty Pharma544292Regulatory approval

OneSource receives USFDA EIR with VAI classification for Bengaluru sterile facility

OneSource Specialty Pharma received the USFDA Establishment Inspection Report with a 'Voluntary Action Indicated' (VAI) classification for its Sterile Product Division facility in Bengaluru.

By ScoutQuest · · 1 min read

USFDA Inspection Outcome
Voluntary Action Indicated (VAI) classification
Inspection Period
June 22 to June 30, 2026
Facility Inspected
Sterile Product Division facility in Bengaluru
Release
Press release

🏭 Managing Director and CEO Neeraj Sharma said the inspection outcome reflects the company's commitment to quality, regulatory compliance and operational excellence, and that the SPD facility plays an integral role in its sterile manufacturing capabilities.

📌 The company says the development adds to its regulatory track record as it builds a CDMO platform spanning four modalities: drug-device combination, biologics, sterile injectables and soft gelatin capsules.

Source: BSE · 30 Oct 2026

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