FDA Inspection 1301788 — Koven Technology, Inc.
The FDA completed an inspection of Koven Technology, Inc. on Feb 6, 2026 in Saint Louis, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Feb 6, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23089 | ISO 13485:2016 Clause 7.1 | Required elements not determined in planning product realization |
| 23131 | ISO 13485:2016 Clause 7.3.9 | Significance of design and development changes not determined |
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23263 | 21 CFR 820.35(a) | Records for complaints involving failure to meet specifications not maintained |