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483
•South Bend Medical Foundation, Inc.•August 1, 2025

South Bend Medical Foundation, Inc. – FDA 483, Aug 1, 2025

Record Details

The FDA inspected South Bend Medical Foundation, Inc., a blood bank and donor center in South Bend, IN. The inspection revealed that written standard operating procedures for blood collection and processing were not consistently followed. This resulted in issues such as incomplete donor reaction logs and the use of outdated controlled forms for quality control and donor reactions.

Company
South Bend Medical Foundation, Inc.
Inspection date
August 1, 2025
Product type
biologics
Office
Detroit District Office
Person
  • Nancy L. Neiger
View Company Profile

ID · a989a820-c888-40c9-95ea-1a5e9575b362

Other documents for South Bend Medical Foundation, Inc.
  • 483 - 2023-09-01September 1, 2023
  • 483 - 2019-08-09August 9, 2019

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