FDA Inspection
Berhane nmi Seyoum, M.D.Berhane nmi Seyoum, M.D. – FDA Inspection, Jul 11, 2016
Record Details
This FDA Inspection record concerns Berhane nmi Seyoum, M.D., with an inspection on July 11, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Berhane nmi Seyoum, M.D.
- Inspection Date
- July 11, 2016
- Product Type
- Drugs
View Company Profile
ID · cb0d25dd-7f1a-4edf-be00-bb437bd20e09
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 978129
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.66Initial and continuing review
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 312.62(a)Accountability records
- 21 CFR 50.20Consent not obtained, exceptions do not apply
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.