FDA EIR - AIT Biosciences - June 28, 2019

An FDA inspection of AIT Bioscience, LLC., in Indianapolis, IN, was conducted from June 24 to June 28, 2019. This surveillance inspection, part of the FY2019 analytical BIMO program, focused on method validation and sample analysis activities for a New Drug Application (NDA) study. The main violation, documented in a Form FDA 483, concerned the firm's failure to adequately establish the long-term matrix stability of certain drug analytes and their metabolites combined in human plasma. Stability was only assessed for one month, despite study samples being stored for up to 72 days, leading to a failure in accuracy for low and high-quality control samples of one analyte. The regulatory framework for this inspection was Compliance Program 7348.004. AIT Bioscience acknowledged the observation and committed to implementing corrective and preventive actions to prevent similar deficiencies in future studies. The firm was required to respond to the Form FDA 483 within 15 business days.