FDA Inspection
San Jorge Children's Hospital IRBSan Jorge Children's Hospital IRB – FDA Inspection, Sep 9, 2015
Record Details
This FDA Inspection record concerns San Jorge Children's Hospital IRB, with an inspection on September 9, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 9, 2015
- Product Type
- Drugs
View Company Profile
ID · 223d38ad-8074-4927-8482-b66be5de0785
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 943160
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.115(b)Retention of records
- 21 CFR 56.111(c)Children as subjects
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
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.