# FDA 483 - American National Red Cross - October 24, 2023

Source: https://www.globalkeysolutions.net/records/483/american-national-red-cross/dd873924-7b3f-4519-905c-548c98331b52

> FDA 483 for American National Red Cross on October 24, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American National Red Cross
- Inspection Date: 2023-10-24
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of American National Red Cross in Rock Hill, SC, identified a critical failure in the proper storage of platelet units. The firm did not immediately store platelets at the required temperature with agitation after collection and resuspension. This lapse raises concerns about the quality and safety of blood products handled at the donor center.

## Related Officers

- [Amy A. Johnson](https://www.globalkeysolutions.net/people/amy-a-johnson/9933f793-503f-45c5-8837-d46134c20e09)

Company: https://www.globalkeysolutions.net/companies/american-national-red-cross/0489c541-f853-47f9-a608-8b6bb2ab08de

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7
