FDA 483 - Laurie Mereu, MD

An FDA inspection of the Division of Endocrinology & Metabolism, Dept. of Medicine in Edmonton, AB, Canada, from July 18-22, 2016, revealed that an investigation was not conducted in accordance with the investigational plan. Specifically, subjects were randomized into a study without the most recent serum creatinine and eGFR results, and temperature monitoring for clinical supplies storage was not consistently performed over several months.