FDA Inspection
Tri Tech Laboratories LLCTri Tech Laboratories LLC – FDA Inspection, Dec 19, 2023
Record Details
This FDA Inspection record concerns Tri Tech Laboratories LLC, with an inspection on December 19, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a83eccec-8b1e-4b58-a267-e94c6131fae5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1227068
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
18- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.111Establishment of time limitations
- 21 CFR 211.111Establishment of time limitations
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Other FDA inspections of Tri Tech Laboratories LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2026 | Not classified | Cincinnati District Office | |
| October 8, 2025 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| July 31, 2024 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| February 25, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Tri Tech Laboratories LLC
- FDA Inspection 1309104 - 2026-05-07
- FDA Inspection 1287684 - 2025-10-08
- FDA Inspection 1242920 - 2024-07-31
- FDA Inspection 961353 - 2016-02-25
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