FDA Inspection 1220458 — Eminent Spine, LLC
The FDA completed an inspection of Eminent Spine, LLC on October 13, 2023 in Plano, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 13, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |