FDA Inspection 1155226 — Smartbox US
The FDA completed an inspection of Smartbox US on October 26, 2021 in Cedar Falls, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 26, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Cedar Falls, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 21425 | 21 CFR 820.184(f) | DHR - UDI not included |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |