483
Joel Vandersluis, M.D.FDA 483 - Joel Vandersluis, M.D. - August 12, 2022
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 Joel Vandersluis, M.D. in Dayton, OH, a clinical investigator, revealed one observation related to the conduct of an investigation. The firm failed to conduct an investigation in accordance with the signed statement of investigator, specifically by not adding a facility performing MRI and PET scans to the Form FDA 1572 in a timely manner. This indicates a lapse in adherence to study protocol and regulatory documentation requirements.
Open in Dashboard
ID · dd72b311-d2b5-4372-867f-d495071beda7