FDA 483 - South Bend Medical Foundation, Inc. - January 07, 2026

South Bend Medical Foundation, Inc., a donor center in South Bend, IN, was cited for deficiencies in phlebotomy site preparation during an FDA inspection. Observations included staff repalpating venipuncture sites after preparation and handling sterile items with bare hands. These practices compromise sterility and pose a greater risk of contamination to whole blood donations.