FDA 483 - Cedars-Sinai Medical Center - August 26, 2022

Cedars-Sinai Medical Center's blood bank in Los Angeles, CA, was cited for multiple significant deficiencies during an FDA inspection. The observations primarily concern failures in donor record management, investigation of discrepancies, notification of deferred donors, and the timely submission of biological product deviation reports. These issues indicate systemic problems with quality control and compliance in blood collection and processing.