FDA 483 - Sumitomo Chemical Co., Ltd. - September 06, 2019

An FDA inspection of Sumitomo Chemical Co., Ltd., an API manufacturer in Anpachi-Gun, Gifu, Japan, revealed significant deficiencies in data integrity, quality unit responsibilities, and certificate of analysis practices. The firm failed to conduct meaningful audit trail reviews for HPLC instruments, improperly delegated critical quality assurance duties, and issued Certificates of Analysis lacking essential information. These issues indicate a lack of adequate controls over manufacturing and quality processes.