FDA Inspection
SpineCraft, LLC.SpineCraft, LLC. – FDA Inspection, Mar 22, 2024
Record Details
This FDA Inspection record concerns SpineCraft, LLC., with an inspection on March 22, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9435c7d6-bd9c-43aa-81e4-7314d53bb8ca
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1233747
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 803.18(b)(1)(i)Adverse events--all info not in file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SpineCraft, LLC.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 14, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 18, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 12, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for SpineCraft, LLC.
- FDA Inspection 1074762 - 2018-12-13
- FDA Inspection 1073334 - 2018-11-14
- FDA Inspection 985974 - 2016-08-18
- FDA Inspection 777309 - 2012-04-12
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