677839
Invacare Corporation — FEI 1525712
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 17, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Elyria, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4436 | 21 CFR 803.40(a) | Report of death, injury |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |