FDA Inspection 1091923 — Matia Robotics US, Inc.
The FDA completed an inspection of Matia Robotics US, Inc. on Jun 5, 2019 in Salt Lake City, UT. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 5, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |