# FDA 483 - Helios Cardio Inc. - March 06, 2026

Source: https://www.keypedia.com/records/483/helios-cardio-inc/4ba49493-6d19-4f1a-bac1-f2de6d149836

> FDA 483 for Helios Cardio Inc. on March 06, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Helios Cardio Inc.
- Inspection Date: 2026-03-06
- Product Type: device
- Office Name: New England District Office
- Summary: Helios Cardio Inc. in Natick, MA, was inspected by the FDA, revealing issues with their quality system. The inspection found that the firm failed to adequately monitor and control outsourced processes, specifically regarding the evaluation of their contract manufacturer for the CardiaMend device. This indicates a moderate concern regarding supplier management and product conformity.

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/helios-cardio-inc/f2cd36dd-d647-4d13-bf82-13d6407a4f2a

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144