# FDA 483 - Cardiomedix Incorporated - July 16, 2021

Source: https://www.keypedia.com/records/483/cardiomedix-incorporated/490c6855-6a34-430b-8d09-71ba4b6c4ce0

> FDA 483 for Cardiomedix Incorporated on July 16, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cardiomedix Incorporated
- Inspection Date: 2021-07-16
- Product Type: device
- Office Name: Chicago District Office
- Summary: Cardiomedix Incorporated, an Own Label Distributor / Initial Importer in Des Plaines, IL, was cited with six observations during an FDA inspection from July 13-16, 2021. The observations primarily concern fundamental deficiencies in the firm's quality system, including a lack of established procedures for complaint handling, supplier control, quality planning, quality policy, management representation, and management review. These issues indicate a significant absence of foundational quality system elements.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/jesse-a-vazquez/cac5b170-d0ea-4355-af5d-3d81546ff0fe)

Company: https://www.keypedia.com/companies/cardiomedix-incorporated/282b4920-b654-4ba9-8826-036cfec74803

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669