FDA Inspection 1109039 — Summit Orthodontic Services Inc
The FDA completed an inspection of Summit Orthodontic Services Inc on November 6, 2019 in Schaumburg, 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
- November 6, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Schaumburg, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |