FDA Inspection
Tris Pharma Inc.Tris Pharma Inc. – FDA Inspection, Mar 20, 2017
Record Details
This FDA Inspection record concerns Tris Pharma Inc., with an inspection on March 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · bbcf743c-d4e0-4c1b-9f1e-81f82bd0e447
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1010216
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Tris Pharma Inc.
13| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2025 | VAI | New Jersey District Office | Drug Quality Assurance |
| March 8, 2024 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 8, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 23, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 16, 2018 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
Other documents for Tris Pharma Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.