FDA Inspection 716353 — Stryker Corporation
The FDA completed an inspection of Stryker Corporation on March 22, 2011 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3347 | 21 CFR 820.200(c) | Service reports/MDRs/complaints |
| 3837 | 21 CFR 820.25(b) | Training records |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |