FDA 483 - CryoSurgery, Inc. - March 09, 2023

CryoSurgery, Inc. in Nashville, TN, was inspected by the FDA from March 6-9, 2023. The inspection revealed two significant observations concerning the lack of established procedures for device history records and inadequate procedures for finished device acceptance. These issues indicate deficiencies in the firm's quality system for manufacturing Class II medical devices.