[UPDATE AS OF OCTOBER 18, 2021]
On October 13, 2021, the U.S. Food and Drug Administration (FDA) revised the inspection classification of the Hikari manufacturing site to Voluntary Action Indicated (VAI). The FDA determined that the conditions in the Warning Letter dated June 2020 have been addressed and the Warning Letter is now closed. Takeda and the FDA will maintain a dialogue regarding ongoing commitments. Takeda has a strong track record of upholding quality standards and has been committed to working closely with the FDA throughout this process.
Takeda confirms that it received a Warning Letter from the U.S. Food and Drug Administration (FDA) related to a routine inspection of the Hikari Plant in Japan in November 2019.
Following the inspection, the FDA made several technical observations about procedures and oversight. After the inspection, Takeda immediately put into place a comprehensive corrective action/preventative action (CAPA) plan and have been providing monthly progress updates to the FDA.
Further, Takeda will respond to the FDA within the targeted timeframe.
Takeda has a strong history of upholding robust quality standards and is committed to working with the FDA to remediate this situation in a timely manner. Patients are Takeda’s first priority. It is Takeda’s position that patient safety is not impacted. We continue to monitor product supply daily.