FDA 483 - SCL Health Front Range Inc. - March 21, 2023

SCL Front Range Inc., a blood bank in Wheat Ridge, CO, was cited for significant procedural and record-keeping deficiencies during an FDA inspection. Observations included failure to follow SOPs for blood storage temperature monitoring, lack of physician signatures for emergency transfusions, and delayed reporting of biological product deviations. These issues indicate a breakdown in quality control and record integrity for critical blood products.