FDA Inspection
Choice Spine LLCChoice Spine LLC – FDA Inspection, Nov 6, 2012
Record Details
This FDA Inspection record concerns Choice Spine LLC, with an inspection on November 6, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Choice Spine LLC
- Inspection Date
- November 6, 2012
- Product Type
- Devices
View Company Profile
ID · ce786aa0-b32f-4668-b887-ad0dd989a199
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 807452
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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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 |
| September 30, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| 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 |
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