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

An FDA inspection of Smith & Nephew Wound Management in Fort Worth, TX, a drug substance and biotech sterile drug manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate investigations into out-of-specification results and adverse events, ineffective corrective actions, and a failure to properly manage and test critical components, leading to sterility failures. These issues highlight serious concerns regarding product quality and patient safety.