# Televere Systems, LLC – FDA 483, Apr 22, 2026

Source: https://www.keypedia.com/records/483/televere-systems-llc/78cd79bf-aa53-4e36-817f-2a0fca3f5fc6

> FDA 483 for Televere Systems, LLC on April 22, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Televere Systems, LLC
- Inspection Date: 2026-04-22
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Televere Systems, LLC in Janesville, WI, a manufacturer of software devices, revealed a significant deficiency in their quality system. The firm failed to adequately document processes for risk management related to their (b) (4) software device. This included a lack of a risk management procedure and a failure to conduct a risk assessment for potential hazards like unclear images or inaccurate measuring tools.

## Related Officers

- [Shawn Choi](https://www.keypedia.com/people/shawn-choi/77845db3-46a3-4d0f-b94c-428bc251c0dc)

Company: https://www.keypedia.com/companies/televere-systems-llc/e585c21e-2bab-4be8-ab6f-8c7e57314594

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d