FDA Inspection
Spinal Advancements-HTSpinal Advancements-HT – FDA Inspection, Aug 3, 2010
Record Details
This FDA Inspection record concerns Spinal Advancements-HT, with an inspection on August 3, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Spinal Advancements-HT
- Inspection Date
- August 3, 2010
- Product Type
- Biologics
View Company Profile
ID · 95bf265d-8080-4a5c-867c-1758bc367f5c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 676606
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.160(a)Program is appropriate for the HCT/Ps
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(f)Return to inventory--procedures
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