FDA 483 - Advanced Research Medical, LLC - December 20, 2022

Advanced Research Medical, LLC, a medical device manufacturer in Burnsville, MN, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate corrective and preventive actions, unvalidated manufacturing and cleaning processes, deficient risk analysis, and a failure to submit a required Medical Device Report. The findings indicate a systemic breakdown in quality management and oversight.