# FDA 483 - SSM-SLUH, Inc. - April 19, 2022

Source: https://www.keypedia.com/records/483/ssm-sluh-inc/232afcd2-c3f9-44c9-8a27-20c582ee0ae7

> FDA 483 for SSM-SLUH, Inc. on April 19, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SSM-SLUH, Inc.
- Inspection Date: 2022-04-19
- 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 across multiple areas. The firm failed to maintain validation records for automated equipment, did not consistently follow procedures for ABO/Rh testing and specimen labeling, and lacked proper maintenance and calibration records for blood processing equipment. Additionally, documentation for emergency blood releases was incomplete, with missing physician and witness signatures.

## Related Documents

- [483 - 2022-04-19](https://www.keypedia.com/records/483/ssm-sluh-inc/663d6a80-1e46-4284-8030-0f831aa7e97e)
- [483 - 2023-02-17](https://www.keypedia.com/records/483/ssm-sluh-inc/14b19afa-6c22-4821-bcb1-f2181e8db1dc)

## 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