# FDA 483 - South Bend Medical Foundation, Inc. - August 09, 2019

Source: https://www.keypedia.com/records/483/south-bend-medical-foundation-inc/25623393-dfc3-402c-a9d3-553ecf8ac6d9

> FDA 483 for South Bend Medical Foundation, Inc. on August 09, 2019. 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: 2019-08-09
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of South Bend Medical Foundation, Inc. identified significant deficiencies in their blood bank and testing laboratory operations. The firm failed to properly investigate severe donor adverse reactions and determine future donor eligibility. Additionally, issues were noted with the documentation of routine equipment maintenance for blood collection and the adherence to cleaning schedules for HCT/P manufacturing equipment.

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## Related Officers

- [Travis S. Bradley](https://www.keypedia.com/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)

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