FDA 483 - South Bend Medical Foundation, Inc. - September 01, 2023

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.