FDA 483 - Blood Connection, Inc. (The) - August 16, 2019

The Blood Connection, Inc. in Raleigh, NC, a blood bank, was inspected from August 14-16, 2019, and cited for a significant deficiency related to computer system validation. The firm failed to maintain proper written records and validation data for its blood establishment computer software. This indicates a serious lapse in data integrity and quality system controls.