FDA 483 - AlloSource - March 30, 2023

An FDA inspection of AlloSource in Centennial, CO, revealed significant deficiencies in process validation for several human tissue allograft products, including PureSkin ™ XL, AlloWrap DS, and AlloWrap Dry. The firm failed to validate processing steps to prevent contamination and the spread of communicable diseases. Additionally, the facility's gowning room and adjacent locker room were not maintained in a clean and sanitary manner, posing further risks of contamination.