FDA Inspection
Tris Pharma Inc.Tris Pharma Inc. – FDA Inspection, Apr 16, 2018
Record Details
This FDA Inspection record concerns Tris Pharma Inc., with an inspection on April 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Marcelo O. Mangalindan (Issuing Officer)
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ID · 868cb111-c9ed-4744-857d-5d267514ece7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048300
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Tris Pharma Inc.
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|---|---|---|---|
| November 21, 2025 | VAI | New Jersey District Office | Drug Quality Assurance |
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| 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 |
| March 20, 2017 | OAI | Center for Drug Evaluation and Research | New Drug Evaluation |
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