FDA Inspection 1305774 — Helios Cardio Inc.
The FDA completed an inspection of Helios Cardio Inc. on March 6, 2026 in Natick, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 6, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Natick, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23024 | ISO 13485:2016 Clause 4.1.5 | Inadequate monitoring and control over outsourced processes |