FDA Inspection 667027 — Spineology, Inc.
The FDA completed an inspection of Spineology, Inc. on Jun 30, 2010 in Saint Paul, MN. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 30, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Saint Paul, MN (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |