FDA Inspection
My Spine Team, LLCMy Spine Team, LLC – FDA Inspection, Nov 8, 2012
Record Details
This FDA Inspection record concerns My Spine Team, LLC, with an inspection on November 8, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- My Spine Team, LLC
- Inspection Date
- November 8, 2012
- Product Type
- Biologics
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ID · c559eca7-dcc9-49f7-8c68-63d767041118
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 803150
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
9- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.160(a)Program is appropriate for the HCT/Ps
- 21 CFR 1271.265(a)Evaluation--microorganisms, damage
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.260(a)Contamination, mix ups, improper release
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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