FDA 483 - CBR Systems Inc - June 14, 2012

An FDA inspection of Cbr Systems Inc's cord blood stem cell facility in Tucson, AZ, revealed two significant observations. The firm failed to verify the effectiveness of corrective actions for leaking cord blood units, some of which were microbially contaminated. Additionally, procedures for validating processes that cannot be fully verified by inspection and tests were not adequately defined, specifically concerning microbiological sampling during aseptic processing.