# FDA 483 - Sanford Clinic North - May 22, 2025

Source: https://www.keypedia.com/records/483/sanford-clinic-north/afcc402a-7ec4-4ad5-afdf-aa134b27f00f

> FDA 483 for Sanford Clinic North on May 22, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanford Clinic North
- Inspection Date: 2025-05-22
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Sanford Clinic North, a hospital blood bank in Fargo, ND, identified a significant deficiency in their adverse reaction investigation procedures. The firm failed to thoroughly investigate reported adverse reactions, specifically regarding transfusions where recipients experienced a rise in temperature, contrary to their own written procedures requiring contamination suspicion and culture. This indicates a lapse in quality control and patient safety protocols.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/emily-a-walters/e80b3581-ffba-4244-9030-b6c9496da932)

Company: https://www.keypedia.com/companies/sanford-clinic-north/dfc42d81-d685-4201-a3a5-4f0f2131a33b

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d