FDA Inspection
Michael Antimisiaris MDMichael Antimisiaris MD – FDA Inspection, Oct 9, 2008
Record Details
This FDA Inspection record concerns Michael Antimisiaris MD, with an inspection on October 9, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Michael Antimisiaris MD
- Inspection Date
- October 9, 2008
- Product Type
- Devices
View Company Profile
ID · d4b24a9b-d281-4ba3-9723-4bb7017819c8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 547952
- 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)(ii)Investigator adverse effect records 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.