FDA Inspection 561367 — Invacare Corporation
The FDA completed an inspection of Invacare Corporation on Feb 9, 2009 in Sanford, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 9, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sanford, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |