FDA 483 - OneBlood, Inc. - January 09, 2026

An FDA inspection of OneBlood, Inc. in Thomasville, GA, on January 9, 2026, revealed a significant concern regarding phlebotomy site preparation. The inspection found that phlebotomists failed to maintain the sterility of the venipuncture site by allowing non-sterile items to touch the disinfected area during whole blood collections. This practice raises concerns about the assurance of a sterile container of Whole Blood.