FDA EIR - Sabates, Dr Nelson - October 26, 2010

An FDA inspection of Sabates, Nelson (Dr. Nelson R. Sabates), conducted from September 22 to October 26, 2010, under the Bioresearch Monitoring Compliance Program, uncovered significant non-compliance in two investigational medication studies. A five-observation Form FDA-483 was issued, citing critical regulatory violations. Key issues included widespread failure to conduct clinical trials according to the investigational plan and protocol, specifically enrolling subjects who met exclusionary criteria, improper use of electronic case report forms, and incomplete safety assessments. The firm also failed to obtain informed consent properly, with subjects not timely re-consented to updated risks as required by 21 CFR Part 50. Crucially, serious adverse events, such as hospitalizations and a brain tumor diagnosis, were not promptly reported to the Institutional Review Board (IRB). Additionally, case histories were inadequate, lacking essential safety data and physician notes, and investigational drug accountability records were incomplete and irreconcilable. Dr. Sabates acknowledged the deficiencies and committed to submitting a written response to the FDA-483 within 15 days. The agency emphasized the investigator's ultimate responsibility for study conduct and warned of potential enforcement actions for continued non-compliance.