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

Source: https://www.keypedia.com/records/483/south-bend-medical-foundation-inc/2da0736c-f17f-43d6-8dc8-367455ee56bf

> FDA 483 for South Bend Medical Foundation, Inc. on September 01, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: South Bend Medical Foundation, Inc.
- Inspection Date: 2023-09-01
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

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## Related Officers

- [investigator](https://www.keypedia.com/people/kaarin-m-slotte/2960bbe1-17ba-4295-9aa8-2514a1595336)

Company: https://www.keypedia.com/companies/south-bend-medical-foundation-inc/8e37e997-d405-42ac-af52-748dc3e744f9

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0