FDA 483 - Smith & Nephew Wound Management - February 26, 2026

An FDA inspection of Smith & Nephew Wound Management in Fort Worth, TX, revealed critical deficiencies in their quality system and materials management. The firm failed to thoroughly investigate discrepancies, ensure effective corrective actions, and properly control components, leading to issues like inadequate OOS investigations, unconfirmed sterility failure root causes, and continued use of failing materials. These findings indicate significant non-compliance in the manufacturing of drug substances and biotech sterile drugs.