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

An FDA inspection of Meiji Seika Pharma Co., Ltd. in Odawara, Japan, revealed significant deficiencies in data integrity, quality control procedures, and discrepancy investigations. Issues included unchecked computer data accuracy, deleted audit trail sequences, uncalibrated equipment, and failures to follow quality unit responsibilities and thoroughly investigate out-of-specification results.