FDA Inspection
Ivy, David Dunbar M.D.Ivy, David Dunbar M.D. – FDA Inspection, Feb 23, 2017
Record Details
This FDA Inspection record concerns Ivy, David Dunbar M.D., with an inspection on February 23, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · e263b8c5-e0b5-49f1-a520-0101fb6f8738
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006029
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 50.27(a)Copy of consent form not provided
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.66Initial and continuing review
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.62(a)Accountability records
- 21 CFR 312.66Changes in research
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
- 21 CFR 50.55(g)Documentation of assent of children
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.