FDA Inspection
James W. Dwyer, M.D.James W. Dwyer, M.D. – FDA Inspection, Jan 31, 2013
Record Details
This FDA Inspection record concerns James W. Dwyer, M.D., with an inspection on January 31, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- James W. Dwyer, M.D.
- Inspection Date
- January 31, 2013
- Product Type
- Devices
View Company Profile
ID · 028a5665-3c1c-4f28-85fe-af09d788e434
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 814576
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 812.110(b)Investigator 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
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.