# FDA 483 - The American National Red Cross - June 27, 2023

Source: https://www.globalkeysolutions.net/records/483/the-american-national-red-cross/31a8199b-56eb-486c-b608-f214709d7518

> FDA 483 for The American National Red Cross on June 27, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The American National Red Cross
- Inspection Date: 2023-06-27
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of The American National Red Cross donor center in Merrillville, IN, revealed a significant quality system deficiency. The firm failed to consistently follow its written standard operating procedures for the storage of blood and blood components. This included a failure to document numerous out-of-range temperature readings and to take immediate corrective actions for these temperature excursions over an extended period.

## Related Officers

- [Erma Zaimova](https://www.globalkeysolutions.net/people/erma-zaimova/87da23ad-48bb-4096-9d8a-e8511c6b5c98)

Company: https://www.globalkeysolutions.net/companies/the-american-national-red-cross/3e51d8d8-9484-4802-82f7-1dcab8d4ee11

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0