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

Ajinomoto Althea, Inc. in San Diego, CA, a sterile drug manufacturer, was cited for two significant issues. The firm's quality control unit failed to consistently reject drug product lots contaminated with stainless steel corrosion particulates. Additionally, investigations into discrepancies and batch failures did not always extend to other potentially affected batches or drug products.