FDA 483 - The Blood Connection, Incorporated - 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 significant compliance issues under the regulatory framework of the Federal Food, Drug, and Cosmetic Act.

Key violations identified include the failure to defer donors who tested reactive for Hepatitis B Surface Antigen (HBsAg) from future donations, despite negative results for other related tests. Additionally, the facility failed to notify donors of their reactive test results for transfusion-transmitted infections, compromising donor awareness and safety.

Furthermore, The Blood Connection distributed biological products, including Apheresis Platelets and Red Blood Cells, across state lines without the necessary biologics license. This action violates FDA regulations requiring proper licensing for interstate commerce of such products.

The FDA has issued a Form 483 to Denise Calloway, Vice President of Operations, detailing these observations. The facility is expected to address these issues promptly, implementing corrective actions to ensure compliance with FDA regulations. The company may discuss objections or corrective plans with the FDA representatives or submit this information to the FDA. Failure to rectify these issues could lead to further regulatory actions.