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