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Nobles Medical Technology II, Inc. was cited for serious violations of investigational device exemption (IDE) regulations (21 CFR Part 812) during an FDA inspection of their NobleStitch EL clinical study, a device intended to close patent foramen ovale and prevent recurrent ischemic stroke. The inspection, conducted by the FDA's Office of Bioresearch Monitoring Operations from October 16-20, 2023, identified objectionable conditions related to sponsor activities and procedures that failed to comply with applicable federal regulations governing clinical investigations. The violations raised concerns about the scientific validity and accuracy of study data as well as the adequacy of human subject protections in the significant risk clinical trial.