FDA Inspection 838149 — Addition Technology Inc
The FDA completed an inspection of Addition Technology Inc on June 28, 2013 in Lombard, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 28, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lombard, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3175 | 21 CFR 820.186 | QSR |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |