FDA Inspection
Synergy Spine Solutions, Inc.FDA Inspection 1292868 - Synergy Spine Solutions, Inc. - November 24, 2025
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Record Details
This FDA Inspection record concerns Synergy Spine Solutions, Inc., with an inspection on November 24, 2025, covering devices.
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ID · 76e438d2-e849-443d-9086-60e51fa64b2e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1292868
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.140(b)(6)Other sponsor records required by FDA inadequate
- 21 CFR 812.40Sponsors' general responsibilities
- 21 CFR 812.46(a)Sponsor securing investigator compliance
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Other FDA inspections of Synergy Spine Solutions, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2025 | Not classified | Denver District Office |