FDA 483 - The Blood Connection, Incorporated - July 16, 2025

The FDA inspected The Blood Connection, Incorporated, a donor center in Savannah, GA, from July 14-16, 2025. The inspection revealed significant deficiencies in the firm's standard operating procedures related to equipment maintenance and calibration, as well as a failure to consistently follow SOPs for the storage of blood and blood components. These issues indicate a lack of adequate control over critical processes for ensuring product quality and safety.