Synergy Health Ede B.V. — FDA Facility Profile
Synergy Health Ede B.V. is an FDA-registered facility (FEI 3002807038) located in Ede Gelderland, NL. Registered operations: STERILIZE. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Feb 12, 2026: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (3 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 12, 2026 | Voluntary Action Indicated (VAI) | Production and service provision not adequate (ISO 13485:2016 Clause 7.5.1) Complaint handling procedures lack required elements (ISO 13485:2016 Clause 8.2.2) |
| Feb 7, 2019 | No Action Indicated (NAI) | No citations listed |
| Dec 3, 2015 | Voluntary Action Indicated (VAI) | No citations listed |
| Jan 30, 2014 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Documentation of software validation (21 CFR 820.70(i)) |
| Mar 9, 2010 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- Synergy Health Ede BV
- Location
- Ede Gelderland (NL)
- Registration Expires
- Dec 31, 2026
- Operations
- STERILIZE
- Source
- both