FDA 483 - Auxilium Medical Inc. - March 26, 2025

Auxilium Medical Inc. in Charleston, SC, a manufacturer of Class II medical devices, was inspected by the FDA from March 24-26, 2025. The inspection revealed significant deficiencies across its quality system, particularly concerning design controls, device master records, purchasing controls, quality audits, management review, and device history records. These issues indicate a broad lack of established procedures and documentation for ensuring device quality and regulatory compliance.