FDA 483 - Biomerics IMP Mebane LLC - October 18, 2024

An FDA inspection of Biomerics IMP Mebane LLC, a contract manufacturer in Mebane, NC, identified significant deficiencies in their quality system. The firm failed to adequately document corrective and preventive actions, properly establish and evaluate customer complaint procedures, and maintain adequate schedules for equipment preventive maintenance. These observations highlight a need for improved adherence to internal procedures and robust quality control.