FDA Inspection
Charles R. McKay, MDCharles R. McKay, MD – FDA Inspection, Mar 6, 2009
Record Details
This FDA Inspection record concerns Charles R. McKay, MD, with an inspection on March 6, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Charles R. McKay, MD
- Inspection Date
- March 6, 2009
- Product Type
- Drugs
View Company Profile
ID · f5ec346b-3ded-42a2-b73f-36e2ab98a1a4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 565722
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
- 21 CFR 312.62(a)Accountability records
- 21 CFR 312.66Changes in research
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.