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

The FDA conducted a Level II inspection of Ajinomoto Althea, Inc., a sterile contract filling facility in San Diego, CA, from January 29 to February 7, 2019. The inspection, focusing on Quality, Labeling, and Packaging Systems, was performed under the regulatory framework of CP 7345.848 for Biological Drug Products (CBER), adhering to Current Good Manufacturing Practice (CGMP) regulations. The inspection revealed multiple significant deficiencies, many of which were persistent, uncorrected issues from previous inspections in 2013, 2015, and 2017. Key violations included inadequately designed manufacturing equipment, specifically a conveyor belt causing vials to fall, which required frequent manual intervention. Investigations into discrepancies lacked proper documentation, root cause analysis, and timely corrective actions. The firm's quality control was found wanting, with unrepresentative product sampling for critical tests, insufficient validation of aseptic processes, and a failure to trend environmental control alarms. Furthermore, the handling of drug product labels was uncontrolled, lacking secure storage and proper identification. Training deficiencies and an inadequate complaint system also contributed to the overall non-compliance. At the conclusion of the inspection, an FDA-483 form detailing these observations was issued to Ajinomoto Althea's management, who acknowledged the findings and committed to implementing corrective actions.