FDA 483 - Abbisko Therapeutics Co., Ltd. - March 20, 2026

An FDA inspection of Abbisko Therapeutics Co., Ltd. in Pudong New Area, Shanghai, China, a commercial sponsor, revealed a significant failure in ensuring a study was conducted according to its protocol and investigational plan. The firm did not adequately oversee a vendor responsible for serious adverse event (SAE) case review and reporting, which led to blinded staff gaining access to unblinded safety information for over seven months. This issue was not discovered by the firm for an extended period, and a corrective action plan was not initiated until much later.