FDA Inspection
Keith Atassi, M.D.Keith Atassi, M.D. – FDA Inspection, Feb 3, 2012
Record Details
This FDA Inspection record concerns Keith Atassi, M.D., with an inspection on February 3, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Keith Atassi, M.D.
- Inspection Date
- February 3, 2012
- Product Type
- Devices
View Company Profile
ID · 8960ca34-b447-44f1-825a-c7aeb80b61b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 766399
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 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)(4)Investigator record of protocol deviations inadequate
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.