# FDA 483 - Cirtec Medical Corp - May 15, 2025

Source: https://www.keypedia.com/records/483/cirtec-medical-corp/3e91f851-8a37-487f-9d50-e0328b72fd74

> FDA 483 for Cirtec Medical Corp on May 15, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Cirtec Medical Corp
- Inspection Date: 2025-05-15
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Cirtec Medical Corp in Brooklyn Park, MN, was cited for inadequate process validation during an FDA inspection. The firm's documentation for an implantable medical device component's manufacturing process failed to demonstrate consistent adherence to specified product requirements. This deficiency poses potential risks to patients, including infections, allergic reactions, and the need for additional surgery.

## 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