FDA 483 - Richard W. Foltin, Ph.D. - June 21, 2019

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.