FDA Inspection
Koven Technology, Inc.Koven Technology, Inc. – FDA Inspection, Feb 6, 2026
Record Details
This FDA Inspection record concerns Koven Technology, Inc., with an inspection on February 6, 2026, issued by the Kansas City District Office, covering medical devices & rad health.
- Company
- Koven Technology, Inc.
- Inspection Date
- February 6, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 76f0a970-b3dd-45ce-9308-9fc17ee38007
Inspection Facts
- Inspection number
- 1301788
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
4- ISO 13485:2016 Clause 7.1Required elements not determined in planning product realization
- ISO 13485:2016 Clause 7.3.9Significance of design and development changes not determined
- ISO 13485:2016 Clause 7.4.1Criteria for the evaluation and selection of suppliers not established
- 21 CFR 820.35(a)Records for complaints involving failure to meet specifications not maintained
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Other FDA inspections of Koven Technology, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 3, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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