FDA 483 - Daiichi Sankyo Chemical Pharma Co., Ltd. - September 01, 2021

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from July 5 to 9, 2021, Daiichi Sankyo Chemical Pharma Co., Ltd. in Iwaki, Fukushima, Japan, a drug substance manufacturer, received an FDA Form 483 detailing two significant observations. The primary issue concerned the inadequacy of equipment cleaning validations for the production of a drug substance. Specifically, the established Dirty Hold Time (DHT) for non-dedicated product contact equipment and certain room equipment lacked sufficient support from cleaning validations. Similarly, the Clean Hold Time (CHT) for room equipment and various tanks was based on only a single validation run, which is insufficient. Furthermore, the company had not successfully completed cleaning validations for all relevant equipment, and its established revalidation intervals were not scientifically justified as per its own procedures. A second observation noted that identity testing for a critical product contact material was not conducted at established intervals upon receipt from the supplier. These observations indicate potential deviations from current Good Manufacturing Practices (cGMP) for drug substances. While not a final determination of non-compliance, the issuance of an FDA 483 requires Daiichi Sankyo Chemical Pharma Co., Ltd. to address these issues by providing a detailed response outlining their proposed corrective and preventative actions to ensure product quality and regulatory compliance.