Thursday, June 18, 2020 Daily Archives

US FDA warns Takeda about Hikari plant

The US FDA has warned Japanese drug firm Takeda about its plant in Hikari, Japan after an inspection conducted last November. According to a letter from the regulator, inspectors who visited the site identified a number of problems with the facility’s quality control unit. The agency wrote, “Our inspection found that your Quality Unit (QU) did not take appropriate steps prior to resumption of aseptic manufacturing after a shutdown that included multiple significant activities that compromised cleanroom control.†It also…