FDA 483 - Institute for In Vitro Sciences, Inc. - June 01, 2022

An FDA inspection of Institute for In Vitro Sciences, Inc. in Gaithersburg, MD, a nonclinical laboratory, revealed two significant observations. The firm failed to adequately test the uniformity and concentration of test and control article mixtures. Additionally, equipment and software used for data generation and assessment, including specific software and Excel spreadsheets, were not adequately validated prior to use in nonclinical studies.