FDA Inspection 1241357 — Zyno Medical LLC
The FDA completed an inspection of Zyno Medical LLC on September 18, 2025 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
- September 18, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Natick, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |