FDA 483 - Preservation Solutions, Inc. - July 14, 2023

An FDA inspection of Preservation Solutions, Inc. in Elkhorn, WI, a manufacturer of organ transplant preservation solutions, revealed significant and persistent deficiencies. The firm was cited for inadequate environmental control procedures, insufficient validation of aseptic processes, and ineffective corrective and preventive actions. These issues are particularly severe as they are repeat observations from multiple prior inspections and were noted in a 2017 Warning Letter.