FDA Inspection
AXIS Spine LLCAXIS Spine LLC – FDA Inspection, Jul 29, 2013
Record Details
This FDA Inspection record concerns AXIS Spine LLC, with an inspection on July 29, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- AXIS Spine LLC
- Inspection Date
- July 29, 2013
- Product Type
- Biologics
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ID · 25122473-3526-4d05-89bb-9ae6946a2802
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 842651
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.200(c)Calibrated per established schedules
- 21 CFR 1271.265(e)Procedures and release criteria
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Other FDA inspections of AXIS Spine LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for AXIS Spine LLC
- FDA Inspection 952461 - 2015-12-21
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