1232735

Tris Pharma Inc. — FEI 3004712471

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 8, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Monmouth Junction, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
683521 CFR 314.80(d)Failure to submit scientific article