FDA Inspection 1305682 — NanoHive Medical LLC
The FDA completed an inspection of NanoHive Medical LLC on March 5, 2026 in Woburn, 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 5, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |