FDA Inspection
Nexxt Spine, LLCNexxt Spine, LLC – FDA Inspection, Aug 11, 2025
Record Details
This FDA Inspection record concerns Nexxt Spine, LLC, with an inspection on August 11, 2025, issued by the Detroit District Office, covering medical devices & rad health.
- Office
- Detroit District Office
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ID · 1f871c0b-6fa0-4d0b-828f-0c054c34cad8
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1279188
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Nexxt Spine, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 30, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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