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483
•South Bend Medical Foundation, Inc.•September 1, 2023

South Bend Medical Foundation, Inc. – FDA 483, Sep 1, 2023

Record Details

The FDA inspected South Bend Medical Foundation, Inc. in South Bend, IN, from August 29 to September 1, 2023. The inspection revealed that the firm failed to follow its written standard operating procedures for recordkeeping, specifically regarding adverse donor event follow-ups and obtaining required blood pressure readings. These findings indicate deficiencies in adherence to established quality control procedures.

Company
South Bend Medical Foundation, Inc.
Inspection date
September 1, 2023
Product type
biologics
Office
Division of Pharmaceutical Quality Operations III
Person
  • Kaarin M. Slotte (investigator)
View Company Profile

ID · 2da0736c-f17f-43d6-8dc8-367455ee56bf

Other documents for South Bend Medical Foundation, Inc.
  • 483 - 2025-08-01August 1, 2025
  • 483 - 2019-08-09August 9, 2019

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