FDA Inspection 1082434 — Dot International
The FDA completed an inspection of Dot International on February 26, 2019 in Evanston, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 26, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Evanston, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |