FDA 483 - Ajinomoto Althea, Inc.

An FDA inspection of Ajinomoto Bio-Pharma Service (Ajinomoto Althea Inc.) in San Diego, CA, revealed significant deficiencies in aseptic processing and equipment maintenance. Inspectors observed operators failing to follow aseptic techniques, inadequate environmental monitoring procedures, and unclean equipment. These issues pose a risk to the sterility and quality of drug products manufactured at the facility.