FDA Inspection 656354 — Stryker Spine
The FDA completed an inspection of Stryker Spine on March 17, 2010 in Allendale, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 17, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Allendale, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3377 | 21 CFR 820.198(e)(3) | Device identification and control number |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |