FDA 483 - Daiichi Sankyo Chemical Pharma Co., Ltd. - July 05, 2021

An FDA inspection of Daiichi Sankyo Chemical Pharma Co., Ltd. in Iwaki, Fukushima, Japan, a drug substance manufacturer, revealed two significant observations. The firm's equipment cleaning validations were found to be inadequate to support established Dirty Hold Time, Clean Hold Time, and revalidation intervals. Additionally, identity testing for a critical material used in drug substance manufacturing was not conducted at established intervals.