# FDA 483 - American Red Cross Blood Services Southwest Region - January 31, 2019

Source: https://www.keypedia.com/records/483/american-red-cross-blood-services-southwest-region/c3e95603-0d67-4503-923b-929421f46eb1

> FDA 483 for American Red Cross Blood Services Southwest Region on January 31, 2019. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: American Red Cross Blood Services Southwest Region
- Inspection Date: 2019-01-31
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of American Red Cross Blood Services Southwest Region in Dallas, TX, identified one observation related to the improper storage of Whole Blood collection sets. The firm failed to follow manufacturer's instructions for storing these sets with Red Cell preservative solution at a controlled room temperature. This indicates a failure to adhere to proper supply and reagent handling procedures.

## Related Officers

- [Decarlos A. Gomez](https://www.keypedia.com/people/decarlos-a-gomez/4b003235-edbb-4cb5-acb1-4e154941578c)

Company: https://www.keypedia.com/companies/american-red-cross-blood-services-southwest-region/3acaafff-962c-42c9-ade0-a2305f355380

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9