Home / Inspections / 1143403

1143403

Tris Pharma Inc. — FEI 3004712471

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 8, 2021
Fiscal Year
2021
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))
  • 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))
  • 1010216 (OAI Mon Mar 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
116221 CFR 211.28(a)Protective Apparel Not Worn
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
202821 CFR 211.192Extent of discrepancy, failure investigations
356521 CFR 211.58Buildings not maintained in good state of repair
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications