FDA Inspection 1003139 — Stryker Medical Division Of Stryker Corporation
The FDA completed an inspection of Stryker Medical Division Of Stryker Corporation on Mar 1, 2017 in Portage, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 1, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Portage, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |