FDA 483 - Biomerics LLC - August 25, 2023

An FDA inspection of Biomerics LLC in Brooklyn Park, MN, from August 21-25, 2023, revealed significant deficiencies in their quality system. Observations included inadequate equipment maintenance schedules and records, poorly defined and implemented complaint handling procedures, and insufficient documentation of acceptance activities and inspection equipment in device history records. These issues indicate a need for improved control over manufacturing processes and quality management.