FDA Inspection
Spinal ElementsSpinal Elements – FDA Inspection, Sep 28, 2017
Record Details
This FDA Inspection record concerns Spinal Elements, with an inspection on September 28, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 00346d9a-abcb-4297-b945-d13d3748d8e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1027047
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Spinal Elements
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 12, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 14, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 5, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Spinal Elements
- FDA Inspection 1002009 - 2017-02-14
- FDA Inspection 903639 - 2014-11-12
- FDA Inspection 831620 - 2013-05-14
- FDA Inspection 704867 - 2011-01-05
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