FDA 483 - Ida Vanessa Doederlein Schwartz, MD - January 31, 2025

An FDA inspection of Ida Vanessa Doederlein Schwartz, MD, a clinical investigator in Porto Alegre, Brazil, revealed inadequate record-keeping practices. The inspection found that investigational drug disposition records were not sufficient, specifically regarding the accurate documentation of discrepancies in investigational product accountability. This indicates a significant issue with data integrity and compliance with study protocols.