FDA 483 - Resolution Biomedical Inc - November 19, 2025

Resolution Biomedical Inc. in Tustin, CA, a repackager, was inspected by the FDA and received a Form 483 with three observations. The inspection revealed significant deficiencies in corrective and preventive action procedures, inadequate personnel training, and a failure to register unique device identifier information in the GUDID. These issues indicate a lack of robust quality system controls, with one observation being a repeat from a previous inspection.