"Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases Warning Letter Details

Summary

Daniel C. Tarquinio, D.O./Center for Rare Neurological Diseases received a warning for violations in the conduct of clinical drug investigations identified during an FDA Bioresearch Monitoring inspection conducted from October 18 to November 5, 2021. The primary violation cited was failure to ensure that clinical investigations were conducted according to the investigational plan, as required under 21 CFR 312.60, specifically regarding subject enrollment procedures in Protocol transition studies. The inspection found that the investigator did not adhere to applicable statutory requirements under the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 312 governing clinical investigations and human subject protection.