FDA Inspection
UCSF Human Islet & Cellular Transplantation FacilityUCSF Human Islet & Cellular Transplantation Facility – FDA Inspection, Dec 10, 2013
Record Details
This FDA Inspection record concerns UCSF Human Islet & Cellular Transplantation Facility, with an inspection on December 10, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 10, 2013
- Product Type
- Biologics
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ID · 89924d35-69a5-4e2f-9d6d-df02259db12d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 858683
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.200(e)Documentation of maintenance and cleaning
- 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
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Other FDA inspections of UCSF Human Islet & Cellular Transplantation Facility
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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