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1048300

Tris Pharma Inc. — FEI 3004712471

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 16, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Monmouth Junction, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

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))
  • 1076980 (OAI Wed Jan 23 2019 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
673021 CFR 314.80(b)Failure to develop written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report