FDA Inspection 1316964 — INSPIREMD Inc
The FDA completed an inspection of INSPIREMD Inc on Jun 18, 2026 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 18, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23064 | ISO 13485:2016 Clause 5.6.2 | Input to management review is incomplete |
| 23213 | ISO 13485:2016 Clause 8.2.1 | Information gathered in feedback process not used as input into risk management |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |