FDA Inspection 1091806 — Clariance Inc
The FDA completed an inspection of Clariance Inc on June 4, 2019 in Dallas, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 4, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |