483
Helios Cardio Inc.Helios Cardio Inc. – FDA 483, Mar 6, 2026
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.
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ID · 4ba49493-6d19-4f1a-bac1-f2de6d149836
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