FDA Inspection 1247165 — Axis Spine Technologies Ltd.
The FDA completed an inspection of Axis Spine Technologies Ltd. on Aug 21, 2024 in Leeds. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 21, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Leeds (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |