FDA 483 - Daito Pharmaceutical Co., Ltd. - September 16, 2022

An FDA inspection of Daito Pharmaceutical Co., Ltd. in Toyama City, Japan, revealed two observations related to quality system deficiencies. The firm failed to adequately investigate unexplained discrepancies and ensure proper follow-up actions. Additionally, the quality control unit did not fully adhere to its responsibilities and procedures, leading to premature closure of deviation reports and approval of change controls before completion.