FDA Inspection 1302456 — Synergy Health Ede BV
The FDA completed an inspection of Synergy Health Ede BV on Feb 12, 2026 in Ede. 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
- Feb 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ede (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 23155 | ISO 13485:2016 Clause 7.5.1 | Production and service provision not adequate |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |