FDA 483 - Missouri Analytical Laboratories, Inc. - September 02, 2022

Missouri Analytical Laboratories Inc, a control testing laboratory in Saint Louis, MO, was cited for significant deficiencies in equipment maintenance. Specifically, a laminar air flow hood used for microbiological testing of drug products was found in disrepair, exhibiting rust, broken glass, and dust, with no airflow visualization studies performed. These conditions raise concerns about the safety, identity, strength, quality, and purity of drug products tested.