FDA 483 - Blood Connection, Inc. (The) - May 27, 2025

The Blood Connection, Inc. in Morrisville, NC, a blood bank, was cited for significant deficiencies during an FDA inspection. Observations included a failure to consistently follow written standard operating procedures for handling returned blood and blood components. Additionally, the firm failed to conduct thorough investigations into unexplained discrepancies, specifically regarding potential contamination of returned platelet units.