483
Dr. Maki , Jeffrey,FDA 483 - Dr. Maki , Jeffrey, - December 21, 2010
Discuss this record with AI
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.
Record Details
An FDA inspection of Dr. Jeffrey H. Maki, a clinical investigator in Seattle, WA, revealed significant deficiencies in the retention of investigational records. The firm failed to retain study records for two different drug study protocols, impacting 132 subjects. This included critical source documents such as informed consent forms, case histories, and drug accountability records.
Open in Dashboard
ID · 94806442-944a-4bc1-827b-ef424de77ac1