# FDA 483 - Regional West Medical Center - February 09, 2023

Source: https://www.globalkeysolutions.net/records/483/regional-west-medical-center/8c6f377e-35c1-4fb6-938b-5b85c8eb533c

> FDA 483 for Regional West Medical Center on February 09, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Regional West Medical Center
- Inspection Date: 2023-02-09
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Regional West Medical Center, a hospital blood bank in Scottsbluff, NE, identified significant deficiencies in record-keeping practices. The firm failed to ensure records adequately identified personnel and provided a complete history of work performed. This included issues with unreviewed donor reaction reports, incomplete blood donor records, and unreviewed blood product disposition and supplier control records.

## Related Officers

- [Ismael Olvera](https://www.globalkeysolutions.net/people/ismael-olvera/0fa45168-6e5f-4eb5-9a3d-4ff8992f84d2)

Company: https://www.globalkeysolutions.net/companies/regional-west-medical-center/38455ed5-1a59-4758-b01a-2af33bd9f12d

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