FDA EIR - Ajinomoto Company Inc. - November 08, 2019

The U.S. Food and Drug Administration conducted an abbreviated Good Manufacturing Practice (GMP) inspection of Ajinomoto Company Inc.'s Kawasaki Plant in Japan from November 5 to November 8, 2019. This inspection, guided by Compliance Program 7356.002F for Active Pharmaceutical Ingredients (APIs), assessed the firm's quality, production, and laboratory control systems for high-volume products exported to the USA. While no formal Form FDA-483 (Inspectional Observations) was issued, the inspection identified and verbally discussed several deficiencies. These included inadequate investigations into Out-of-Specification (OOS) results (though not cited for lots supplied to non-U.S. markets), the presence of a water puddle in a Class 100,000 room, and inadequate process validation procedures. The inspection concluded with a "No Action Indicated" classification, meaning no immediate formal regulatory action was required. However, the FDA recommended a re-inspection based on a CDER risk assessment, indicating continued regulatory oversight and the expectation for the company to address the identified issues internally.