# FDA 483 - American Red Cross National Headquarters - May 19, 2014

Source: https://www.keypedia.com/records/483/american-red-cross-national-headquarters/42377de7-049c-4126-ae25-095dfa559ee5

> FDA 483 for American Red Cross National Headquarters on May 19, 2014. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Red Cross National Headquarters
- Inspection Date: 2014-05-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: The American National Red Cross, Biomedical Services, in Washington, D.C., was cited for multiple significant deficiencies during an FDA inspection. These issues include inadequate validation of its ePROGESA computer system, ineffective quarantine procedures leading to the reissuance of unsuitable blood products, and failures in distribution traceability. Additionally, the firm did not conduct thorough investigations, submit timely biological product deviation reports, maintain concurrent records, or comply with specific paragraphs of a consent decree regarding notifications and document provision.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/linda-s-mattingly/4abdc255-a72e-475f-b3e3-1b68bf94d3b8)
- [Jennifer A. Jones](https://www.keypedia.com/people/jennifer-a-jones/c84da44c-2d7b-431d-ad85-ae164747c4e9)
- [Investigator](https://www.keypedia.com/people/laurie-a-haxel/d93490cc-9d85-48c4-8f27-314c5344b312)

Company: https://www.keypedia.com/companies/american-red-cross-national-headquarters/7e199447-a26a-4047-b6b9-ff2cd862a988

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e