FDA Inspection
Wayne J. Olan, M.D., Clinical InvestigatorWayne J. Olan, M.D., Clinical Investigator – FDA Inspection, Jul 30, 2012
Record Details
This FDA Inspection record concerns Wayne J. Olan, M.D., Clinical Investigator, with an inspection on July 30, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 30, 2012
- Product Type
- Devices
View Company Profile
ID · 94a8a360-77f3-456d-a4e5-d5728fdba064
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 792374
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 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)(2)(i)Investigator device accountability inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Wayne J. Olan, M.D., Clinical Investigator
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Wayne J. Olan, M.D., Clinical Investigator
- FDA Inspection 876306 - 2014-04-28
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.