Helios Cardio Inc.March 6, 2026

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Helios Cardio Inc.

Record Details

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.

Company: Helios Cardio Inc.
Inspection Date: March 6, 2026
Product Type: Device
Office: New England District Office
Person: James P. Finn (investigator)

Open in Dashboard

ID · 4ba49493-6d19-4f1a-bac1-f2de6d149836