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FDA Inspection 1114642 — OneSource Specialty Pharma Limited

OneSource Specialty Pharma Limited — FEI 3003813519

The FDA completed an inspection of OneSource Specialty Pharma Limited on December 20, 2019 in Bengaluru. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 20, 2019
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bengaluru (India)

Citations

IDCFRDescription
202721 CFR 211.192Investigations of discrepancies, failures

Facility

Other inspections at this facility

  • 1234275 (VAI Thu Mar 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1044193 (VAI Tue Mar 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 963420 (VAI Wed Mar 16 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 890880 (OAI Fri Aug 08 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 847764 (VAI Mon Aug 12 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources