FDA Inspection 752758 — OsteoSymbionics LLC
The FDA completed an inspection of OsteoSymbionics LLC on November 3, 2011 in Cleveland, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 3, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cleveland, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3672 | 21 CFR 820.30(c) | Design input - review and approval |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |