FDA Inspection 852552 — SPINEART SA
The FDA completed an inspection of SPINEART SA on Sep 10, 2013 in Plan-Les-Ouates. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 10, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Plan-Les-Ouates (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |