FDA 483 - Sumitomo Osaka Cement Co.,Ltd. - October 27, 2023

Sumitomo Osaka Cement Co., Ltd., an API manufacturer in Osaka, Japan, received a Form 483 citing significant deficiencies in its quality systems. Issues include an inadequate cleaning validation program, deficient Out of Specification (OOS) investigations lacking corrective and preventive actions (CAPA), and failure to establish the reliability of component supplier analyses. Furthermore, the quality unit did not fully adhere to its responsibilities, and audit trail reviews for analytical data were found to be inadequate, indicating a critical data integrity gap.