FDA 483 - Hycor Biomedical LLC - November 26, 2025

Hycor Biomedical LLC in Garden Grove, CA, was inspected by the FDA from November 19-26, 2025. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning complaint handling and corrective and preventive actions. The firm failed to adequately investigate complaints involving device specification failures and did not properly conduct or document root cause analyses for nonconformances.