FDA Inspection
Life Spine, LLC.Life Spine, LLC. – FDA Inspection, May 2, 2025
Record Details
This FDA Inspection record concerns Life Spine, LLC., with an inspection on May 2, 2025, issued by the Chicago District Office, covering medical devices & rad health.
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ID · 7908a372-1400-4435-ba1b-65453a815bb5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1268745
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(d)Records of MDR Investigation
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Other FDA inspections of Life Spine, LLC.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 9, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 22, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 15, 2009 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Life Spine, LLC.
- FDA Inspection 885395 - 2014-06-30
- FDA Inspection 702312 - 2010-11-09
- FDA Inspection 709509 - 2010-10-22
- FDA Inspection 591759 - 2009-06-15
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