FDA Inspection 610928 — Stryker Corporation
The FDA completed an inspection of Stryker Corporation on August 31, 2009 in San Jose, CA. 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
- August 31, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |