Company
NetherlandsSynergy Health Ede BV, Ede Gld, Netherlands – FDA Inspections
Inspection records and compliance data for Synergy Health Ede BV in Ede Gld. 6 FDA inspections on record, 1 Form 483, last inspected February 12, 2026.
Company Profile
This profile covers Synergy Health Ede BV based in Ede Gld, Netherlands.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 9, 2010. Last inspected February 12, 2026.
Most cited issue areas
- Complaint handling procedures lack required elements1 inspection
- Documentation of software validation1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 12, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1302456 |
| December 21, 2023 | Not classified | Medical Devices & Rad Health | 1228147 |
| February 7, 2019 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1089775 |
| December 3, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 952967 |
| January 30, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 864292 |
| March 9, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 654360 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
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Company Information
Name
Synergy Health Ede BV
FEI Number
3002807038
Address
Morsestraat 3, Ede Gld, Netherlands
Country
Netherlands
ID: 2274689d-2c32-4dca-8e6e-8d36efb8e433