FDA 483 - Ajinomoto Althea, Inc. - January 16, 2023

Ajinomoto Althea, Inc. DBA Ajinomoto Bio-Pharma Services in San Diego, CA, was inspected and received a Form 483 with three observations. The inspection revealed deficiencies in quality oversight of validation activities, facility and equipment maintenance, and adherence to quality control unit procedures. These issues indicate a need for improved GMP compliance in critical manufacturing and laboratory operations.