FDA 483 - Smith & Nephew Wound Management - July 20, 2019

Smith & Nephew, Inc. in Fort Worth, TX, a biological drug substance and drug product manufacturer, received a Form 483 with seven observations during an inspection from July 12-20, 2021. The observations primarily highlight significant deficiencies in aseptic processing, environmental controls, quality control unit oversight, and record-keeping practices for sterile drug products like (b) (4) ointment and gel. These issues indicate a lack of adherence to cGMP requirements, posing potential risks to product sterility and quality.