FDA 483 - RenatiLabs Inc - August 12, 2022

An FDA inspection of RenatiLabs Inc in Erlanger, KY, a manufacturer of WJMAX umbilical cord tissue product, revealed significant deficiencies in aseptic processing and quality control. The firm failed to adequately validate its aseptic manufacturing process, establish proper production controls, and conduct necessary stability and sterility testing. Additionally, environmental monitoring and cleaning procedures in aseptic areas were found to be inadequate.