FDA 483 - Ajinomoto Althea, Inc. - April 06, 2017

An FDA inspection of Ajinomoto Althea, Inc., a sterile drug manufacturer in San Diego, CA, revealed significant deficiencies in their quality control and manufacturing operations. Observations included inadequate written procedures for cleaning and maintenance, unapproved laboratory control mechanisms, and a failure to follow established laboratory protocols. These issues indicate a need for improved oversight and adherence to good manufacturing practices.