FDA 483 - Adrian Wlodarczak - December 07, 2018

An FDA inspection of Adrian Wlodarczak, Principal Investigator, in Lubin, Poland, revealed significant deviations from the investigational plan for Protocol EFC 11570. The firm failed to adhere to the study protocol, leading to issues with sample collection, analysis, and timely reporting of critical study events. These findings indicate a serious lack of compliance with clinical trial procedures.