FDA Inspection 1012817 — Caliber Imaging and Diagnostics, Inc.
The FDA completed an inspection of Caliber Imaging and Diagnostics, Inc. on June 1, 2017 in Rochester, NY. 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 1, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rochester, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |