483
South Bend Medical Foundation, Inc.FDA 483 - South Bend Medical Foundation, Inc. - August 09, 2019
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An FDA inspection of South Bend Medical Foundation, Inc. identified significant deficiencies in their blood bank and testing laboratory operations. The firm failed to properly investigate severe donor adverse reactions and determine future donor eligibility. Additionally, issues were noted with the documentation of routine equipment maintenance for blood collection and the adherence to cleaning schedules for HCT/P manufacturing equipment.
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ID · 25623393-dfc3-402c-a9d3-553ecf8ac6d9