FDA Inspection
Naval Medical Center San Diego IRBNaval Medical Center San Diego IRB – FDA Inspection, Nov 20, 2019
Record Details
This FDA Inspection record concerns Naval Medical Center San Diego IRB, with an inspection on November 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 20, 2019
- Product Type
- Devices
View Company Profile
ID · c673e59f-4fb2-4119-8dfb-9530ed1bab90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1110514
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.109(b)Information given to subjects
Full citation text and observation details available on the Dashboard.
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.