FDA 483 - Ajinomoto Althea, Inc. - September 20, 2023

Ajinomoto Althea, Inc. DBA Ajinomoto Bio-Pharma Services in San Diego, CA, was cited for significant deficiencies in microbial cross-contamination control and aseptic processing procedures. The inspection also found inadequate complaint investigations regarding particulate matter in finished drug products. These issues indicate a lack of robust quality control and adherence to sterile manufacturing practices.