483
Richard W. Foltin, Ph.D.FDA 483 - Richard W. Foltin, Ph.D. - June 21, 2019
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
The FDA inspected Foltin Richard W in New York, NY, and issued a Form 483 with two observations. The inspection revealed that investigations were not conducted according to the investigational plan, with subjects enrolled despite not meeting exclusion criteria and vital signs being inconsistently recorded or altered. Additionally, the firm failed to maintain accurate case histories, showing discrepancies in recorded vital signs and their corresponding timestamps.
Open in Dashboard
ID · c247810a-a983-49a0-b680-b9135befa765