FDA Inspection
International Cellular Medicine Society IRBInternational Cellular Medicine Society IRB – FDA Inspection, Jun 19, 2012
Record Details
This FDA Inspection record concerns International Cellular Medicine Society IRB, with an inspection on June 19, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 19, 2012
- Product Type
- Biologics
View Company Profile
ID · a8ad9330-a0ef-4b58-9579-743263d0768b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 788874
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(b)Retention of records
- 21 CFR 56.107(d)One non-affiliate member
- 21 CFR 56.107(c)One scientific and one non-scientific member
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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.