FDA Inspection
Max Spine, LLCMax Spine, LLC – FDA Inspection, Jan 27, 2014
Record Details
This FDA Inspection record concerns Max Spine, LLC, with an inspection on January 27, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Max Spine, LLC
- Inspection Date
- January 27, 2014
- Product Type
- Biologics
View Company Profile
ID · 73c66a66-c148-4e54-8e2f-9a75a2fd425b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 865391
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.265(e)Documentation elements for activities
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.265(e)Procedures and release criteria
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Max Spine, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 27, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Max Spine, LLC
- FDA Inspection 989064 - 2016-08-18
- FDA Inspection 796336 - 2012-08-27
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