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

An FDA inspection of clinical investigator Ann R. Woodbridge, M.D., operating in Dallas, TX, occurred from January 18 to January 24, 2022. This preannounced, mission-critical inspection, conducted under Compliance Program 7348.811 for Clinical Investigators, sought to confirm the integrity of study data supporting a New Drug Application and ensure compliance with FDA regulatory requirements.

The inspection resulted in one observation issued on Form FDA 483, indicating that the investigation was not conducted in accordance with the investigational plan. Specifically, three of nineteen enrolled subjects met bone mineral density discontinuation criteria as outlined in the protocol, but their withdrawal was delayed. This delay occurred because Dual-energy X-ray Absorptiometry (DEXA) scans were not submitted to the Central Reader within 24 hours of acquisition, or repeat scans were not performed and submitted within five business days of a query, causing subjects to continue receiving the investigational product inappropriately.

Dr. Woodbridge acknowledged the observation, attributing the issue to a backup coordinator's lack of access to the online portal for scan uploads. As a corrective action, all coordinators now have necessary portal access for backup duties. Dr. Woodbridge also committed to submitting a formal written response to the FDA observation, referencing 21 CFR 312.60.