FDA 483 - Sumitomo Osaka Cement Co.,Ltd. - October 27, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
The inspection of Sumitomo Osaka Cement Co., Ltd. in Kaizuka-shi, Japan, an API manufacturer, revealed significant deficiencies across multiple quality system areas. These include inadequate cleaning validation, deficient Out-of-Specification (OOS) investigations without proper CAPA, unreliable supplier qualification, and a quality unit failing to fulfill its responsibilities. Furthermore, the firm's audit trail review for analytical data was found to be inadequate, indicating potential data integrity issues.
ID · 25bf28e5-409d-4e67-9587-b50f3de7bd31