# FDA 483 - SSM-SLUH, Inc. - February 17, 2023

Source: https://www.keypedia.com/records/483/ssm-sluh-inc/14b19afa-6c22-4821-bcb1-f2181e8db1dc

> FDA 483 for SSM-SLUH, Inc. on February 17, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SSM-SLUH, Inc.
- Inspection Date: 2023-02-17
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of SSM-SLUH, Inc., a hospital blood bank in Saint Louis, MO, revealed significant deficiencies in quality control and adherence to standard operating procedures. The firm failed to maintain adequate validation records for automated processes and did not properly investigate unexplained discrepancies related to emergency blood releases. Additionally, employees did not consistently follow written procedures for blood component processing and storage, and equipment validation plans were found to be inadequate.

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## Related Officers

- [Esther A. Ofori](https://www.keypedia.com/people/esther-a-ofori/98108fae-1e09-4849-bceb-18e69dff7ba4)

Company: https://www.keypedia.com/companies/ssm-sluh-inc/0b38f0ea-991f-4ef2-a1e1-fc27bda1ea90

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8