FDA 483 - Kathleen M. Mullane, D.O. - October 20, 2020

Kathleen M. Mullane, Clinical Investigator, was inspected by the FDA, revealing significant deviations from investigational plans and inadequate record-keeping. The inspection found instances where study drugs were administered contrary to protocol, prohibited medications were given, and eligibility assessments were not properly documented. Additionally, serious adverse events were not reported to the sponsor within the required timeframe, and case histories lacked essential data.