FDA 483 - Sato Pharmaceutical Co., Ltd. - October 25, 2019

Sato Pharmaceutical Co., Ltd. in Hachioji, Tokyo, Japan, was inspected by the FDA from October 17-25, 2019, revealing significant deficiencies in equipment cleaning, data integrity, quality control, and warehouse management. The inspection found issues including inadequate cleaning validation for production line hoses, lack of control over electronic records and alarm histories, and insufficient procedures for warehousing and batch record documentation. These findings indicate a general lack of robust quality systems and controls for drug products distributed to the United States.