# FDA 483 - Koven Technology, Inc. - February 06, 2026

Source: https://www.keypedia.com/records/483/koven-technology-inc/f6f56e86-90f3-42ff-be09-0ca848d0038d

> FDA 483 for Koven Technology, Inc. on February 06, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Koven Technology, Inc.
- Inspection Date: 2026-02-06
- Product Type: device
- Office Name: Kansas City District Office
- Summary: An FDA inspection of Koven Technology, Inc., a manufacturer and distributor of medical devices including fetal dopplers, revealed significant quality system deficiencies. The firm failed to document design changes for expanding fetal indications of use, inadequately maintained complaint records, and lacked proper criteria for evaluating and managing a critical foreign supplier. Additionally, risk management analyses for fetal dopplers did not adequately assess fetal-specific hazards.

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/koven-technology-inc/2a1f4139-f4b1-4a2f-9b20-53bdec21f5e4

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79