FDA 483 - Sigrid Blome-Eberwein - September 28, 2020

Sigrid Blome-Eberwein, MD, a Clinical Investigator in Allentown, PA, was issued a Form 483 following an FDA inspection from September 10-28, 2020. The inspection revealed that an investigation was not conducted in accordance with the investigational plan. Specifically, issues were noted with the recording of information for subjects randomized to a standard of care.