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ExThera Medical Corporation was cited for objectionable conditions observed during a Bioresearch Monitoring Program inspection of two investigational device studies involving the Seraph 100 Microbind Affinity Blood Filter and Onco-Seraph 100 blood filter devices, which are used to remove pathogens and circulating tumor cells from patient blood. The inspection, conducted from May 27 to June 4, 2025, evaluated whether the company's activities and procedures as a clinical study sponsor complied with federal regulations governing significant risk investigational device exemption studies. The FDA requested prompt corrective action to address violations identified during the inspection, with the company having submitted written responses on June 25, July 25, and September 15, 2025.