FDA Inspection
Republic Spine, LLCRepublic Spine, LLC – FDA Inspection, Mar 14, 2018
Record Details
This FDA Inspection record concerns Republic Spine, LLC, with an inspection on March 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ff1c3f8f-152b-4ba4-ac22-37e7a796977c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044363
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Republic Spine, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2025 | NAI | Florida District Office | Postmarket Assurance: Medical Devices |
| April 3, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 31, 2021 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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