Synergy Spine Solutions, Inc. - Inspection Records

Inspection records and compliance data for Synergy Spine Solutions, Inc. in Louisville, Colorado. 2 FDA inspections on record, 1 Form 483, last inspected November 24, 2025.

Company Profile

This profile covers Synergy Spine Solutions, Inc. based in Louisville, Colorado, United States.

FDA Inspection History

FDA inspections: 2
OAI: 0
VAI: 1
NAI: 0
Unclassified: 1
Form 483s: 1
Warning letters: 0

First inspected September 11, 2025. Last inspected November 24, 2025.

Most cited issue areas

Other sponsor records required by FDA inadequate1 inspection
Sponsor securing investigator compliance1 inspection
Sponsors' general responsibilities1 inspection

Most recent inspections

Date	Classification	Office	Project area
November 24, 2025	VAI	Denver District Office	Product Evaluation: Medical Devices
September 11, 2025	Not classified	Denver District Office

Documents (4)

483 - Synergy Spine Solutions, Inc. - 2025-11-24

483

FDA Inspection 1292868 - Synergy Spine Solutions, Inc. - 2025-11-24

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FDA Inspection 1292868 - Synergy Spine Solutions, Inc. - 2025-11-24

fda_inspection

FDA Inspection 1282036 - Synergy Spine Solutions, Inc. - 2025-09-11

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