FDA Inspection
SSM Helathcare St Louis IRBSSM Helathcare St Louis IRB – FDA Inspection, Mar 6, 2012
Record Details
This FDA Inspection record concerns SSM Helathcare St Louis IRB, with an inspection on March 6, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- SSM Helathcare St Louis IRB
- Inspection Date
- March 6, 2012
- Product Type
- Biologics
View Company Profile
ID · 33124415-e6f8-41e7-8e55-ceba6afd50eb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 771898
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.107(f)Invited individual allowed to vote with IRB
- 21 CFR 56.110(b)Research not eligible for expedited review
- 21 CFR 56.110(c)Method to keep members advised
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.