FDA Inspection
Emerson Hospital Human Rights CommitteeEmerson Hospital Human Rights Committee – FDA Inspection, Jul 24, 2014
Record Details
This FDA Inspection record concerns Emerson Hospital Human Rights Committee, with an inspection on July 24, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 24, 2014
- Product Type
- Drugs
View Company Profile
ID · 60385ad1-bc4d-4377-ab6d-006837cbc0c3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 887799
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 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.