FDA 483 - Smith & Nephew Wound Management - September 30, 2022

Smith & Nephew, Inc. in Fort Worth, TX, a biological drug substance and drug product manufacturer, received a Form 483 with four observations. The inspection revealed failures in following stability study testing programs, inadequate written procedures for production and process controls, deficiencies in quality control unit procedures, and issues with facilities and equipment ensuring consistent process performance. These issues indicate significant concerns regarding product quality and manufacturing control.