FDA Inspection 991323 — KORR Medical Technologies, Inc.
The FDA completed an inspection of KORR Medical Technologies, Inc. on Nov 7, 2016 in Salt Lake City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 7, 2016
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3159 | 21 CFR 820.184 | DHR content |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |