FDA 483 - Ajinomoto Althea, Inc. - May 25, 2021

An FDA inspection of Ajinomoto Althea, Inc., a sterile drug manufacturer in San Diego, CA, revealed significant deficiencies in contamination control, cleaning procedures for highly toxic compounds, and laboratory controls. The firm's risk assessments for active pharmaceutical ingredients (APIs) were inadequate, and cleaning methods failed to address the most toxic compounds used in shared manufacturing suites. Additionally, laboratory testing procedures for impurity analysis were found to be lacking, resulting in under-reported impurities.