Company: American Red Cross Transplantation Services
Product: Cryopreserved heart valves
Date: 3/11/04

The cryopreservation process dated 5/19/95, Computer Rate Controlled Freezer for Cryopreservation of Human Tissue, was not adequate. The validation included determining the maximum tolerance limits of the cryopreservation unit to freeze heart valves at a specified rate but only cryopreservation solution was used, not heart valves or a simulated product. [21 CFR 820.75 (a)]

FDA District: Los Angeles District Office