FDA Inspection 866382 — Axiomed Spine Corporation
The FDA completed an inspection of Axiomed Spine Corporation on Feb 14, 2014 in Cleveland, OH. 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
- Feb 14, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Cleveland, OH (United States)
Additional details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |