FDA Inspection 1279137 — Tri-anim Health Services, Inc.
The FDA completed an inspection of Tri-anim Health Services, Inc. on August 21, 2025 in Dublin, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 21, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dublin, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |