FDA 483 - Sawai Pharmaceutical Co., Ltd. - October 15, 2019

Sawai Pharmaceutical Co., Ltd. in Kamisu, Ibaraki, Japan, a drug manufacturer, was inspected and cited for significant deficiencies across its quality control, equipment maintenance, and data integrity practices. The inspection revealed inadequate endotoxin testing for its (b) (4) Injection, poor control over electronic records and critical equipment, and improper storage of clean equipment, all of which compromise drug product quality and data reliability. These issues indicate a systemic failure to adhere to appropriate manufacturing and laboratory control standards.