# FDA 483 - Cirtec Medical Corporation - February 25, 2021

Source: https://www.keypedia.com/records/483/cirtec-medical-corporation/089626c6-9202-472a-b36e-58cdb77a2ba8

> FDA 483 for Cirtec Medical Corporation on February 25, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cirtec Medical Corporation
- Inspection Date: 2021-02-25
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Cirtec Medical Corporation in Brooklyn Park, MN, revealed significant deficiencies in their corrective and preventive action (CAPA) procedures. The firm failed to adequately verify the effectiveness of corrective actions for complaints and CAPAs, and did not follow its own procedures for submitting extension requests for overdue CAPAs. These issues indicate a breakdown in the quality system for ensuring device safety and effectiveness.

## Related Officers

- [investigator](https://www.keypedia.com/people/jennifer-s-ness/532f8a81-e393-4e83-b5f2-a72362e966de)

Company: https://www.keypedia.com/companies/cirtec-medical-corporation/d9b02c6b-039c-4981-a7a6-f2a2861d0f38

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