483
Robert L. Tychsen, MDRobert L. Tychsen, MD – FDA 483, Mar 11, 2022
Record Details
An FDA inspection of Robert L. Tychsen, MD, a clinical investigator in St Louis, MO, revealed significant deficiencies in the protection of human subjects. Observations included failures to obtain informed consent prior to study procedures and discrepancies in the documentation of consent. Additionally, subject case history records were found to be inaccurate or incomplete, with issues regarding original consent forms and participant identification.
View Company Profile
ID · 422df7c8-f1ff-4378-a59c-2f99915d91fa
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.