# FDA 483 - American National Red Cross - December 10, 2025

Source: https://www.keypedia.com/records/483/american-national-red-cross/8f32465b-1864-4a1a-8e36-00b545de4fb4

> FDA 483 for American National Red Cross on December 10, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American National Red Cross
- Inspection Date: 2025-12-10
- Product Type: biologics
- Office Name: FDA District Office — Denver, Colorado
- Summary: An FDA inspection of the American National Red Cross donor center in Lehi, UT, identified two significant deficiencies. The firm failed to adequately explain the risks and hazards of the apheresis procedure to donors during the consenting process. Additionally, standard operating procedures lacked a written description and method for controlling the storage temperatures of platelets awaiting transport to manufacturing.

## Related Officers

- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/american-national-red-cross/393b29f4-e6b9-4558-87b7-139fc34ea1ac

Office: https://www.keypedia.com/offices/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0