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1076980

Tris Pharma Inc. — FEI 3004712471

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 23, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Monmouth Junction, NJ (United States)

Facility

Other inspections at this facility

  • 1289086 (VAI Fri Nov 21 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1232735 (VAI Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1143403 (VAI Tue Jun 08 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1048300 (VAI Mon Apr 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1010216 (OAI Mon Mar 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures