CMIC Pharma Science Co., Ltd. – FDA 483, Aug 31, 2026

CMIC Pharma Science Co., Ltd., a contract testing laboratory in Ishikari, Japan, was cited for significant deficiencies in data integrity, equipment qualification, and analytical method validation. The inspection revealed issues including the use of unvalidated Excel spreadsheets for critical calculations, incomplete performance qualification for HPLC systems, and a lack of method transfer or site-specific validation for analytical test procedures. These findings indicate a serious lack of control over data and testing processes for drug products.