# FDA 483 - William S. Middleton Memorial Veteran's Hospital - May 08, 2025

Source: https://www.globalkeysolutions.net/records/483/william-s-middleton-memorial-veterans-hospital/b9716c4f-b10b-493f-8d4a-40c047986120

> FDA 483 for William S. Middleton Memorial Veteran's Hospital on May 08, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: William S. Middleton Memorial Veteran's Hospital
- Inspection Date: 2025-05-08
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of William S. Middleton Memorial Veteran's Hospital's Blood Bank revealed significant deficiencies. The facility failed to maintain proper temperatures for Red Blood Cells during shipment, leading to units being re-issued and transfused despite temperature excursions. Additionally, issues were noted with concurrent record-keeping for blood component storage and distribution, adherence to written standard operating procedures for product inspection, and the maintenance of quality control and general records for equipment.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.globalkeysolutions.net/companies/william-s-middleton-memorial-veterans-hospital/2b834068-29d2-4dd7-9490-3deb09474b62

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