FDA 483 - Daiichi Sankyo Chemical Pharma Co., Ltd. - December 22, 2023

An FDA inspection of Daiichi Sankyo Chemical Pharma Co., Ltd.'s manufacturing facility in Iwaki, Fukushima, Japan, conducted from December 18 to December 22, 2023, identified two significant observations. The first observation detailed a failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results. Specifically, an active pharmaceutical ingredient batch exceeding its target yield range was distributed without a conclusive root cause identified. Additionally, investigations into an OOS raw material assay result and foreign matter found in another raw material were deemed inadequate, lacking confirmed root causes, preventive controls, or assessment of potential impacts. The second observation highlighted the absence of adequate written procedures for production and process controls designed to ensure drug product quality. The inspection found no production controls to prevent residue build-up in equipment during multi-batch manufacturing campaigns for an active pharmaceutical ingredient, with no scheduled cleaning between batches. Evidence of residue in equipment after routine cleanings in July 2022 and July 2023 underscored this deficiency. These findings indicate areas where the company's quality management system and manufacturing processes require improvement to comply with regulatory standards, necessitating comprehensive corrective and preventive actions from the firm.