FDA Inspection 806763 — Stryker Corporation
The FDA completed an inspection of Stryker Corporation on November 9, 2012 in Portage, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 9, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Portage, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |