FDA 483 - Ajinomoto Althea, Inc. - February 09, 2023

Ajinomoto Althea, Inc. in San Diego, a biological drug product manufacturer, was inspected by the FDA from February 2-9, 2023. The inspection revealed significant deficiencies across multiple areas, primarily concerning aseptic processing controls, quality unit responsibilities, and laboratory controls. Key issues included inadequate smoke studies, poor aseptic techniques, lack of data integrity controls, and untimely deviation management, indicating a potential compromise to product sterility and overall quality assurance.