FDA Inspection 640016 — Osseolink USA, LLC
The FDA completed an inspection of Osseolink USA, LLC on January 8, 2010 in Fort Washington, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 8, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fort Washington, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2648 | 21 CFR 820.30(f) | Design verification procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |