FDA Inspection 991205 — Sontec Instruments, Inc
The FDA completed an inspection of Sontec Instruments, Inc on Oct 21, 2016 in Centennial, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 21, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Centennial, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |