# Cirtec Medical Corp – FDA 483, Jan 13, 2026

Source: https://www.keypedia.com/records/483/cirtec-medical-corp/cdb1fdcd-62ad-4726-b310-749a961e5cff

> FDA 483 for Cirtec Medical Corp on January 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cirtec Medical Corp
- Inspection Date: 2026-01-13
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Cirtec Medical Corp. in Brooklyn Park, MN, a medical device manufacturer, received a Form FDA 483 following an inspection from January 7-13, 2026. The inspection revealed deficiencies in process validation, specifically concerning inadequate documentation of training for personnel involved in laser weld protocols. This indicates a moderate severity issue related to quality system controls.

## Related Documents

- [483 - 2025-05-15](https://www.keypedia.com/records/483/cirtec-medical-corp/3e91f851-8a37-487f-9d50-e0328b72fd74) — date: May 15, 2025

## Related Officers

- [investigator](https://www.keypedia.com/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)

Company: https://www.keypedia.com/companies/cirtec-medical-corp/24c9b2fe-2afe-47a7-8f53-28ba42bdbad1

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