FDA 483 - TOLMAR, Inc. - June 17, 2022

TOLMAR, Inc. in Windsor, CO, was inspected and cited for four observations related to manufacturing controls for its Paliperidone Palmitate Extended-Release Injectable Suspension. Deficiencies included inadequate equipment design, lack of material qualification for API samples, unestablished test method sensitivity, and insufficient cleaning procedures. These issues indicate a lack of control over aseptic processing, material quality, and laboratory testing, posing potential risks to product sterility and quality.