FDA 483 - Missouri Analytical Laboratories, Inc. - May 19, 2021

Missouri Analytical Laboratories Inc, a contract testing laboratory in Saint Louis, MO, was cited for significant quality control and data integrity issues during an FDA inspection. The firm's Quality Unit failed to ensure compliance with procedures, leading to falsification of records, inadequate investigations of out-of-specification results, and a lack of proper training. Additionally, the inspection revealed poor computer system controls and incomplete laboratory records.