FDA Inspection
UCSF Human Islet & Cellular Transplantation FacilityUCSF Human Islet & Cellular Transplantation Facility – FDA Inspection, Mar 31, 2010
Record Details
This FDA Inspection record concerns UCSF Human Islet & Cellular Transplantation Facility, with an inspection on March 31, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 31, 2010
- Product Type
- Biologics
View Company Profile
ID · e598f6ee-5099-4141-a4a3-396d19489a54
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 655703
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
13- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.180(d)Adopted from another organization
- 21 CFR 1271.265(c)(3)Departures: recorded and justified
- 21 CFR 1271.210(d)(3)Lot documentation maintained
- 21 CFR 1271.350(b)(1)Deviations not investigated
- 21 CFR 1271.350(b)(2)Deviations not reported to FDA
- 21 CFR 1271.370(a)Clear and accurate label
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.225Verification/validation
Showing 10 of 13 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of UCSF Human Islet & Cellular Transplantation Facility
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 10, 2013 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for UCSF Human Islet & Cellular Transplantation Facility
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.