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Warning Letter

Case 534537 — FEI 3004712471

Facility

Recent inspections

  • 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))
  • 1048300 (VAI Mon Apr 16 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Action Details

Facility
Tris Pharma Inc.
Date
March 28, 2018
Fiscal Year
2018
Product Type
Drugs
Center
CDER
Location
Monmouth Junction, NJ (United States)