FDA 483 - Hycor Biomedical LLC - November 26, 2025

Hycor Biomedical LLC, a manufacturer in Garden Grove, CA, was inspected by the FDA, revealing significant deficiencies in its quality system. The firm failed to adequately investigate customer complaints involving device specification failures and did not properly document corrective and preventive action (CAPA) activities, specifically regarding root cause analyses. These observations indicate a lack of adherence to established internal procedures for quality control.