# FDA 483 - South Bend Medical Foundation, Inc. - August 01, 2025

Source: https://www.globalkeysolutions.net/records/483/south-bend-medical-foundation-inc/a989a820-c888-40c9-95ea-1a5e9575b362

> FDA 483 for South Bend Medical Foundation, Inc. on August 01, 2025. 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: 2025-08-01
- Product Type: biologics
- Office Name: Detroit District Office
- Summary: 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 This resulted in issues such as incomplete donor reaction logs and the use of outdated controlled forms for quality control and donor reactions.

## Related Documents

- [483 - 2019-08-09](https://www.globalkeysolutions.net/records/483/south-bend-medical-foundation-inc/25623393-dfc3-402c-a9d3-553ecf8ac6d9)
- [483 - 2023-09-01](https://www.globalkeysolutions.net/records/483/south-bend-medical-foundation-inc/2da0736c-f17f-43d6-8dc8-367455ee56bf)

## Related Officers

- [Nancy L. Neiger](https://www.globalkeysolutions.net/people/nancy-l-neiger/c3209528-eeb3-4a5f-88b1-f503798ed4c5)

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

Office: https://www.globalkeysolutions.net/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03