FDA Inspection 1149871 — Osseofuse International Inc.
The FDA completed an inspection of Osseofuse International Inc. on Aug 26, 2021 in Las Vegas, NV. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 26, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Las Vegas, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |