FDA Inspection
Alfonso Eduardo, MDAlfonso Eduardo, MD – FDA Inspection, Apr 16, 2014
Record Details
This FDA Inspection record concerns Alfonso Eduardo, MD, with an inspection on April 16, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Alfonso Eduardo, MD
- Inspection Date
- April 16, 2014
- Product Type
- Devices
View Company Profile
ID · d9b56ee8-b875-4e87-aa95-6b77b0cdfc5e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 875423
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
7- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.100Investigator lack of informed consent
- 21 CFR 812.140(a)(3)(ii)Investigator adverse effect records inadequate
- 21 CFR 812.140(a)(2)(i)Investigator device accountability inadequate
- 21 CFR 812.140(a)(1)Investigator correspondence records inadequate
- 21 CFR 812.100No investigator protection - subject rights, safety, welfare
- 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.