FDA Inspection
Choice Spine LLCChoice Spine LLC – FDA Inspection, Sep 30, 2019
Record Details
This FDA Inspection record concerns Choice Spine LLC, with an inspection on September 30, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · a8b330cb-3ad4-4de3-af1f-006fc8a1cc9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1103332
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 1271.260(d)Corrective actions
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Choice Spine LLC
8| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 10, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 22, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 25, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 31, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Choice Spine LLC
- FDA Inspection 1191985 - 2022-11-04
- FDA Inspection 1022504 - 2017-08-10
- FDA Inspection 966606 - 2016-02-22
- FDA Inspection 943610 - 2015-09-25
- FDA Inspection 853612 - 2013-10-31
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