FDA 483 - Daiichi Sankyo Chemical Pharma Co., Ltd. - April 30, 2021

An FDA inspection revealed significant quality system deficiencies at Daiichi Sankyo Chemical Pharma Co., Ltd.'s Tatebayashi Plant, a drug substance intermediate manufacturer. While specific inspection dates were not provided, observations span a period from June 2020 to April 2021. The findings, issued under the regulatory framework of Current Good Manufacturing Practices (cGMP), include critical issues such as manufacturing processes not being followed, with multiple batches reprocessed without approved steps and subsequently released without proper regulatory authorization. Corrective and preventative actions (CAPAs) for these deviations were found to be ineffective.

A recurring observation noted a lack of independence for the Quality Assurance unit, as the security pharmacist oversaw Quality Assurance, Quality Control, and Production. The facility's deviation and CAPA management system was deemed inadequate, highlighted by a severely delayed and un-implemented CAPA for an environmental monitoring excursion, and an investigation into a power outage affecting critical QC data servers that concluded no CAPA was needed despite a six-day data storage interruption. Furthermore, written standard operating procedures for facility cleaning and disinfecting lacked validated instructions for cleaning agent contact times. Lastly, pest control procedures were insufficient, with repeated pest excursions addressed by temporary fixes and observation of tall grasses near manufacturing buildings.

Daiichi Sankyo is required to provide a comprehensive response detailing immediate and preventative corrective actions for each observation.