FDA Inspection
Synergy Health Ede BVSynergy Health Ede BV – FDA Inspection, Feb 12, 2026
Record Details
This FDA Inspection record concerns Synergy Health Ede BV, with an inspection on February 12, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Synergy Health Ede BV
- Inspection Date
- February 12, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 28f5d3bc-8b4a-45ad-8ab6-87efde12d41d
Inspection Facts
- Inspection number
- 1302456
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
2- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
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Other FDA inspections of Synergy Health Ede BV
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2023 | Not classified | Office of Inspections and Investigations | |
| February 7, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 3, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 9, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Synergy Health Ede BV
- FDA Inspection 1228147 - 2023-12-21
- FDA Inspection 1089775 - 2019-02-07
- FDA Inspection 952967 - 2015-12-03
- FDA Inspection 864292 - 2014-01-30
- FDA Inspection 654360 - 2010-03-09
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