FDA Inspection
UCSF Human Research Protection ProgramUCSF Human Research Protection Program – FDA Inspection, Feb 20, 2009
Record Details
This FDA Inspection record concerns UCSF Human Research Protection Program, with an inspection on February 20, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 20, 2009
- Product Type
- Devices
View Company Profile
ID · 650f1f85-28f5-4617-9b7c-3d36cf980034
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 565083
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.113Reporting
Full citation text and observation details available on the Dashboard.
Other FDA inspections of UCSF Human Research Protection Program
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2023 | NAI | Bioresearch Monitoring | |
| March 29, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| February 17, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| February 25, 2011 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
Other documents for UCSF Human Research Protection Program
- FDA Inspection 1217623 - 2023-08-03
- FDA Inspection 1052205 - 2018-03-29
- FDA Inspection 1011639 - 2017-02-17
- FDA Inspection 711994 - 2011-02-25
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.