FDA 483 - Sabeen Najam, MD - January 20, 2021

An FDA inspection of Sabeen Najam, MD, a clinical investigator in Baytown, TX, revealed significant deficiencies in the conduct of an investigation. The firm failed to adhere to the investigational plan, with critical issues identified in data integrity and record-keeping. Specifically, unverified modifications to source documents, lack of investigator awareness of changes, and improper dating and signing of clinical assessments and adverse event reports were observed.