FDA 483 - Preservation Solutions, Inc. - June 06, 2025

Preservation Solutions, Inc. in Elkhorn, WI, was inspected regarding its manufacturing of CoStorSol Cold Storage Solution. The inspection revealed significant and repeat deficiencies in corrective and preventive action procedures, environmental control, and software validation. These issues indicate a systemic lack of adequate quality system controls, some of which have been recurring since 2015 and were noted in a previous Warning Letter.