940361
Invacare Corporation — FEI 3002889431
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 9, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Elyria, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 10005 | n/a | Procedural requirements |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |