FDA Inspection 1305822 — Reflow Medical
The FDA completed an inspection of Reflow Medical on March 5, 2026 in Lake Forest, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were 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
- Lake Forest, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23140 | ISO 13485:2016 Clause 7.4.1 | Supplier evaluation and selection criteria do not include required elements |
| 23261 | ISO 13485:2016 Clause 8.5.3 | Preventive action procedures not documented |