FDA Inspection
David H. W. Wohns, M.D.David H. W. Wohns, M.D. – FDA Inspection, Nov 24, 2015
Record Details
This FDA Inspection record concerns David H. W. Wohns, M.D., with an inspection on November 24, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- David H. W. Wohns, M.D.
- Inspection Date
- November 24, 2015
- Product Type
- Devices
View Company Profile
ID · cac457fb-9190-4c8d-91bb-3687560d54c7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 954091
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 50.20Consent not obtained, exceptions do not apply
- 21 CFR 50.20Exculpatory language, waiving of rights
- 21 CFR 50.25(c)ClincialTrials.gov statement
- 21 CFR 812.100No investigator protection - subject rights, safety, welfare
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.