FDA 483 - Gene Logic, Inc. - March 25, 2024

An FDA inspection of BASI Gaithersburg, LLC dba Inotiv Gaithersburg, a non-clinical laboratory, revealed deficiencies in their standard operating procedures. The firm's written procedures for nonclinical laboratory studies were found to be inadequate in ensuring the quality and integrity of generated data, specifically failing to require accurate recording of original experimental data.