FDA 483 - Meiji Seika Pharmatech Co., Ltd. - April 08, 2022

Meiji Seika Pharma Co., Ltd. in Odawara, Japan, was inspected and cited for significant deficiencies across its laboratory and quality systems. Observations included widespread data integrity issues, failures in quality control unit procedures, and inadequate investigation of unexplained discrepancies. These issues indicate a lack of robust controls over data accuracy, quality processes, and deviation management.