FDA 483 - Ajinomoto Althea, Inc. - May 09, 2025

Ajinomoto Althea, Inc., a sterile drug manufacturer in San Diego, CA, was cited for significant deficiencies during an FDA inspection. Observations included widespread poor aseptic practices, inadequate validation of sterilization processes, deficient cleaning and disinfection systems, and a failure to investigate unexplained discrepancies. Additionally, the quality control unit's procedures were not fully followed, and laboratory controls lacked scientifically sound test procedures.