FDA Inspection
Buttner-janz, Karin, Prof Dr. MedButtner-janz, Karin, Prof Dr. Med – FDA Inspection, Apr 9, 2010
Record Details
This FDA Inspection record concerns Buttner-janz, Karin, Prof Dr. Med, with an inspection on April 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 9, 2010
- Product Type
- Devices
View Company Profile
ID · 6aa04f31-27ef-413c-8534-dbcdeef14ab2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 660561
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.150(a)(1)Investigator report of unanticipated adverse effects
- 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)(ii)Investigator records of relevant observations inadequate
- 21 CFR 812.110(d)Inadequate financial disclosure by investigator
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.