FDA 483 - Blood Connection Inc (The) - June 12, 2025

The FDA conducted an inspection of The Blood Connection, Incorporated, a collection facility located at 2115 S Main Street, Suite E, Wake Forest, NC, from June 10 to June 12, 2025. The inspection revealed several critical compliance issues. Firstly, the facility failed to defer donors who tested reactive for Hepatitis B Surface Antigen (HBsAg) in screening tests, which is crucial for preventing the transmission of infections through blood donations. Specifically, donors tested positive for HBsAg on April 12, 2025, and November 19, 2024, were not deferred from future donations.

Additionally, the facility did not notify these donors of their test results, which is a significant lapse in donor communication and safety protocols. Furthermore, The Blood Connection distributed biological products, including Apheresis Platelets and Red Blood Cells, across state lines without the necessary biologics license, violating federal regulations.

These observations were reported under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which mandates the FDA to ensure that food, drugs, and biologics are not prepared, packed, or held under conditions that could render them harmful. The Blood Connection is required to address these violations by implementing corrective actions to ensure compliance with FDA regulations and to prevent potential health risks associated with blood transfusions.