FDA 483 - Ajinomoto Althea, Inc. - February 07, 2019

Ajinomoto Althea, Inc. in San Diego, CA, a sterile product manufacturer, was cited for multiple deficiencies during an FDA inspection. Key issues include inadequate equipment design leading to product vials falling, insufficient investigation into discrepancies and particulate defects, and unrepresentative sampling of drug products. Additionally, the firm failed to adequately validate aseptic processes, control temperature/humidity alarms, and maintain strict control over the storage and access of labeling materials.