FDA Inspection
Tris Pharma Inc.Tris Pharma Inc. – FDA Inspection, Mar 8, 2024
Record Details
This FDA Inspection record concerns Tris Pharma Inc., with an inspection on March 8, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 99d56376-6034-4b6d-bb10-9c0588ba3b2d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1232735
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(d)Failure to submit scientific article
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Tris Pharma Inc.
13| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2025 | VAI | New Jersey District Office | Drug Quality Assurance |
| 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 |
| March 20, 2017 | OAI | Center for Drug Evaluation and Research | New Drug Evaluation |
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