FDA 483 - Christopher Romero, M.D. - August 09, 2024

An FDA inspection of Panamerican Clinical Research Llc in Brownsville, TX, a clinical investigator, revealed significant deviations from the investigational plan. The firm failed to maintain proper documentation for subject immunizations and inclusion/exclusion criteria, and did not adequately evaluate or report adverse events as defined by the study protocol. These findings indicate serious deficiencies in the conduct of clinical research.