FDA Inspection 968326 — Force Diagnostics Inc
The FDA completed an inspection of Force Diagnostics Inc on April 13, 2016 in Rolling Meadows, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 13, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rolling Meadows, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |