FDA 483 - Advanced Research Medical, LLC - October 01, 2025

Advanced Research Medical, LLC, a medical device manufacturer in Burnsville, MN, received a Form FDA-483 citing significant quality system deficiencies. Observations included inadequate risk analysis, unmitigated corrective and preventive actions, and insufficient process validation for its medical devices. The firm also failed to adequately establish complaint handling procedures and did not submit required Medical Device Reports for serious device malfunctions.