FDA Inspection
Moussa C. Mansour, MDMoussa C. Mansour, MD – FDA Inspection, Oct 15, 2013
Record Details
This FDA Inspection record concerns Moussa C. Mansour, MD, with an inspection on October 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Moussa C. Mansour, MD
- Inspection Date
- October 15, 2013
- Product Type
- Devices
View Company Profile
ID · 6fdf354c-5160-41d4-9e79-866c1b3482a7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 851689
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 812.140(a)(3)(i)Investigator records of informed consent inadequate
- 21 CFR 812.140(a)(3)Investigator"s subject records inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Moussa C. Mansour, MD
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 19, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Moussa C. Mansour, MD
- FDA Inspection 950458 - 2015-11-19
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.