FDA 483 - Prof. Thomas Zeller, M.D. - May 25, 2018

An FDA inspection of Prof. Thomas Zeller, M.D., a clinical investigator in Bad Krozingen, Germany, revealed significant deviations from the investigational plan. The inspection found that subjects were enrolled who did not meet protocol criteria and that a serious adverse event was not reported to the sponsor within the required timeframe. These findings indicate a failure to adhere to study protocols and regulatory expectations for clinical investigations.