FDA 483 - Ono Pharmaceutical Co., Ltd. - December 17, 2018

An FDA inspection of Ono Pharmaceutical Co., Ltd in Fujinomia-shi, Japan, revealed significant deficiencies in their drug manufacturing operations. Observations included inadequate equipment cleaning procedures, a lack of scientifically sound laboratory test procedures for drug product conformity, and failures within the quality control unit to properly review data. These issues suggest a need for improved adherence to Good Manufacturing Practices to ensure product quality and purity.