FDA 483 - Pau Montesinos, M.D. - January 18, 2019

An FDA inspection of Pau Montesinos, Clinical Investigator, in Valencia, Spain, revealed significant deviations from the investigational plan and proper study conduct. Observations included improper dispensing of study drug to an unauthorized person and multiple failures to adhere to protocol requirements for subject assessments and laboratory testing. Additionally, the firm failed to maintain accurate and complete case histories for several subjects.