# FDA 483 - American Red Cross Blood Services - November 24, 2008

Source: https://www.keypedia.com/records/483/american-red-cross-blood-services/6c362b12-5ee5-4e34-8e7e-d3c80a5e896d

> FDA 483 for American Red Cross Blood Services on November 24, 2008. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Red Cross Blood Services
- Inspection Date: 2008-11-24
- Office Name: New England District Office
- Summary: This FDA Form 483 document outlines observations made during an inspection of a facility involved in the distribution of blood and blood components. The primary observation noted is the "Failure to adequately investigate, correct, and prevent recurring problem of distributing blood and blood components without ice to consignees." This indicates a systemic issue within the facility's operations related to temperature control during transit, which is critical for maintaining the integrity and safety of blood products.

Furthermore, the document states, "Written procedure was not followed regarding handling of Management of Suspect Products." This suggests a breakdown in adherence to established quality system procedures, specifically concerning how products deemed "suspect" are managed. This non-compliance with written procedures could lead to inadequate control over potentially compromised blood products, posing a risk to recipients. The recurring nature of the "without ice" problem highlights a deficiency in the facility's corrective and preventive action (CAPA) system, indicating that previous attempts to resolve the issue have been ineffective. These observations point to significant quality system and manufacturing issues that require immediate attention to ensure compliance with regulatory requirements and the safety of distributed blood products.

## Related Documents

- [483 - 2010-06-15](https://www.keypedia.com/records/483/american-red-cross-blood-services/12cf48b1-ec45-45b0-a4b2-d11507f7be5c)

## Related Officers

- [Investigator](https://www.keypedia.com/people/alice-silva/b4b46db5-2b1a-452c-a403-9265a8785330)

Company: https://www.keypedia.com/companies/american-red-cross-blood-services/98e91618-bcb1-4225-8499-2868e90f0c9a

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144