FDA Inspection
Nexxt Spine, LLCNexxt Spine, LLC – FDA Inspection, Apr 27, 2018
Record Details
This FDA Inspection record concerns Nexxt Spine, LLC, with an inspection on April 27, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f7019798-d9d9-47b2-b1c0-3a21203ac5f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053731
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of Nexxt Spine, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2025 | NAI | Detroit District Office | Postmarket Assurance: Medical Devices |
| December 30, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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