FDA Inspection 1318078 — FLOW NEUROSCIENCE AB
The FDA completed an inspection of FLOW NEUROSCIENCE AB on May 21, 2026 in Malmo. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 21, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Malmo (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 23024 | ISO 13485:2016 Clause 4.1.5 | Inadequate monitoring and control over outsourced processes |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |