FDA 483 - Ann R. Woodbridge, M.D. - January 24, 2022

An FDA inspection of Ann R. Woodbridge, M.D., a clinical investigator in Dallas, TX, revealed a significant deviation from the investigational plan. The firm failed to ensure timely submission of bone mineral density scans, leading to delays in identifying and discontinuing subjects who met withdrawal criteria from a study. This indicates a failure to adhere to study protocols and ensure subject safety and data integrity.