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Talk to a SpecialistTalk to a SpecialistUnited Health Products, Inc. was cited for serious violations of FDA regulations governing investigational device exemptions (21 CFR Part 812) and human subject protection (21 CFR Part 50) during a September-October 2024 inspection of their clinical study for CelluSTAT Absorbable Hemostat, a medical device intended to manage bleeding in surgical settings. The FDA's Office of Bioresearch Monitoring identified objectionable conditions in the company's activities and procedures as study sponsor for a significant risk clinical trial, raising concerns about the scientific validity of data and the adequacy of human subject protections. The company had submitted a written response to the violations on October 25, 2024, and was directed to take prompt corrective action to address the compliance failures.