FDA 483 - Preservation Solutions, Inc. - September 30, 2021

The FDA inspection of Preservation Solutions, Inc. in Elkhorn, WI, revealed critical deficiencies across multiple quality system areas, many of which are repeat observations. The firm failed to adequately control environmental conditions in Class 5 cleanrooms, validate key processes, implement effective corrective and preventive actions, and properly investigate complaints, including those linked to patient deaths. These systemic failures indicate a lack of control over the manufacturing of organ transplant preservation solutions, posing significant risks to product sterility and patient safety.