FDA 483 - Northern California Community Blood Bank - December 16, 2022

Northern California Community Blood Bank in Eureka, CA, was inspected and cited for multiple significant deficiencies related to quality control and recordkeeping. Observations included failures to review records before product release, inadequate investigations into discrepancies, and deficiencies in standard operating procedures. Additionally, issues with equipment usage and facility cleanliness were noted, indicating a need for comprehensive procedural and operational improvements.