"Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases – FDA Warning Letter, Nov 5, 2021

This Warning Letter, FDA Ref. No.: 22-HFD-45-03-05, dated April 5, 2022, addresses objectionable conditions observed during an FDA inspection of Dr. Tarquinio's clinical site from October 18 to November 5, 2021. The inspection, part of the Bioresearch Monitoring Program, reviewed clinical investigations of the investigational drug (b)(4) for (b)(4).

The primary violation cited is the failure to ensure the investigation was conducted according to the investigational plan, specifically 21 CFR 312.60. Dr. Tarquinio enrolled subjects in Protocol (b)(4) and its open-label extension, Protocol (b)(4), who were simultaneously enrolled and actively participating in another clinical study, Protocol (b)(4), involving a different investigational drug ((b)(4)). This violated the inclusion/exclusion criteria for both Protocol (b)(4) and Protocol (b)(4), which required exclusion of subjects (b)(4) or those (b)(4) respectively. Four specific examples of dual enrollment were provided.

Dr. Tarquinio's November 24, 2021, response to the Form FDA 483 acknowledged the issue, citing verbal clarifications from the sponsor's medical monitor regarding exclusion criteria and the rarity of the subject population. Corrective and preventive actions included