FDA EIR - Ajinomoto Company Inc. - November 05, 2019

An FDA inspection of Ajinomoto Company Inc.'s Kawasaki Plant, a non-sterile Active Pharmaceutical Ingredient (API) manufacturer, was conducted from November 5 to November 8, 2019. This abbreviated Good Manufacturing Practice (GMP) inspection, performed under Compliance Program 7356.002F for API Process Inspection, focused on several high-volume products exported to the U.S. and covered the Quality, Production, and partial Laboratory Control Systems. While the inspection concluded with a "No Action Indicated" (NAI) classification and no official Form FDA-483 observations were issued, several deficiencies were discussed verbally with the firm. These included inadequate investigations into Out-of-Specification results (though not cited for lots supplied only to non-U.S. markets), a water puddle observed in a Class 100,000 cleanroom, and insufficient process validation procedures. The firm is expected to address these verbal observations, and a re-inspection is planned based on a CDER risk assessment.