FDA 483 - Reprise Biomedical, Inc. - November 20, 2025

An FDA inspection was conducted at Reprise Biomedical, Inc. from November 19-20, 2025, resulting in the issuance of an FDA Form 483. The main violation observed was an inadequate risk analysis for the company's Miro3D wound matrix product. Specifically, the firm's risk documents, including the Miro3D Design FMEA and Miro3D UFMEA, did not adequately consider the potential harm of death as a consequence of patient infection due to the use of a nonsterile product. The maximum severity level assigned for patient infection was listed as "Serious," requiring medical or surgical intervention, which does not encompass the full range of severe outcomes. This observation indicates a deficiency in the firm's quality system and risk management practices, falling under the regulatory purview of the Federal Food, Drug, and Cosmetic Act. Reprise Biomedical, Inc. is required to respond to this observation by either discussing any objections with the FDA or by implementing corrective actions to ensure their risk assessments are comprehensive and account for all potential severe harms.