FDA Inspection
BioBancUSABioBancUSA – FDA Inspection, Jul 27, 2011
Record Details
This FDA Inspection record concerns BioBancUSA, with an inspection on July 27, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- BioBancUSA
- Inspection Date
- July 27, 2011
- Product Type
- Biologics
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ID · 4a9ed79c-e589-4631-8f97-9ee1e7b24d58
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 738000
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.160(b)(3)Problem description, disposition, date et. al.
- 21 CFR 1271.210(d)(1)Receipt documentation maintained
- 21 CFR 1271.170(b)Qualifications lacking
- 21 CFR 1271.200(b)Procedures inadequate
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Other FDA inspections of BioBancUSA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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