FDA 483 - Ajinomoto Althea, Inc. - May 18, 2015

Ajinomoto Althea, Inc. in San Diego, CA, a sterile drug manufacturer, was inspected from May 6-18, 2015. The inspection revealed deficiencies in written procedures for preventing microbiological contamination during sterile drug product transfer and in the validation of component supplier test results for bioprocessing bags. These issues indicate a moderate level of concern regarding sterility assurance and quality control.