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FDA Inspection
•Synergy Spine Solutions, Inc.•November 24, 2025

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, issued by the Denver District Office, covering medical devices & rad health.

Company
Synergy Spine Solutions, Inc.
Inspection Date
November 24, 2025
Product Type
Medical Devices & Rad Health
Office
Denver District Office
Person
  • Theressa B. Smith (Issuing Officer)
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ID · dd42a26c-b53e-4256-9251-fec1b78ae6a0

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
Product Evaluation: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 812.140(b)(6)Other sponsor records required by FDA inadequate
  2. 21 CFR 812.40Sponsors' general responsibilities
  3. 21 CFR 812.46(a)Sponsor securing investigator compliance

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Synergy Spine Solutions, Inc.

1
DateClassificationOfficeProject area
September 11, 2025Not classifiedDenver District Office
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