FDA Inspection
Synergy Health Ede BVSynergy Health Ede BV – FDA Inspection, Jan 30, 2014
Record Details
This FDA Inspection record concerns Synergy Health Ede BV, with an inspection on January 30, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Synergy Health Ede BV
- Inspection Date
- January 30, 2014
- Product Type
- Devices
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ID · d485e90c-c2a8-4810-aba0-860d450c20da
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 864292
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(i)Documentation of software validation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Synergy Health Ede BV
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| 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 |
| March 9, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Synergy Health Ede BV
- FDA Inspection 1302456 - 2026-02-12
- FDA Inspection 1228147 - 2023-12-21
- FDA Inspection 1089775 - 2019-02-07
- FDA Inspection 952967 - 2015-12-03
- FDA Inspection 654360 - 2010-03-09
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