FDA 483 - Ajinomoto Health & Nutrition North America, Inc. - November 13, 2023

An FDA inspection of Ajinomoto Health & Nutrition North America, Inc. in Eddyville, IA, revealed significant deficiencies in the manufacturing of crude intermediates for active pharmaceutical ingredients. The firm lacked a quality control unit, proper process validation, and scientific justification for hold times and shelf-life. Additionally, issues were noted with incomplete batch records and inadequate controls for electronic data integrity.