FDA 483 - Chester V. Oddis, MD - April 29, 2021

An FDA inspection of Chester V. Oddis, MD, a clinical investigator in Pittsburgh, PA, revealed significant deficiencies in conducting an investigational study. Observations included failures to follow the investigational plan, improper subject enrollment, inconsistent dose calculations, and inaccurate adverse event reporting in case histories. These issues indicate a lack of adherence to clinical trial regulations and could impact subject safety and data integrity.