FDA 483 - Battelle Biomedical Research Center - August 05, 2021

An FDA inspection of Battelle Memorial Institute's Non-Clinical Laboratory in West Jefferson, OH, revealed significant deviations from study protocols. Observations included failures to conduct studies in accordance with established protocols, inadequate identification of specimens, and the study director's failure to ensure proper approval and adherence to protocol changes. These findings indicate issues with study conduct, record-keeping, and oversight within the facility.