FDA 483 - Adam I. Frome, MD - August 18, 2025

An FDA inspection of Adam I. Frome, MD, a clinical investigator in Shenandoah, TX, revealed significant deficiencies in the conduct of clinical trials. Observations included failures to adhere to investigational plans by enrolling ineligible subjects, conducting study procedures before obtaining informed consent, and maintaining adequate and accurate case histories with proper documentation. These issues indicate a lack of control over critical aspects of clinical study conduct and data integrity.