FDA Inspection 1116415 — Invacare Corporation
The FDA completed an inspection of Invacare Corporation on Jan 31, 2020 in Elyria, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 31, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Elyria, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |