# FDA 483 - American Red Cross Blood Services - June 15, 2010

Source: https://www.keypedia.com/records/483/american-red-cross-blood-services/12cf48b1-ec45-45b0-a4b2-d11507f7be5c

> FDA 483 for American Red Cross Blood Services on June 15, 2010. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Red Cross Blood Services
- Inspection Date: 2010-06-15
- Product Type: Devices
- Office Name: New England District Office
- Summary: The FDA Form 483 details multiple observations from an inspection of a blood collection operation, likely the American Red Cross, concerning deficiencies in their mobile blood drive procedures and quality systems.

**Violations and Observations:**

1.  **Inadequate SOPs and Non-Adherence to Procedures:**
    *   Written SOPs for blood collection, specifically American Red Cross Job Aid 15.4J608 and Document 15.3.079, lack specific environmental conditions (e.g., temperature parameters) for mobile site setup.
    *   Blood drives were operated despite noted deficiencies in environmental conditions.
    *   **Temperature Issues:** Multiple instances of blood drives operating in very cold conditions (59-62°F) at Tully Health Center - Stamford (2/27/2010, 3/13/2010) and Philip R. Smith Elementary School (2/8/2010), causing discomfort to staff/volunteers and requiring heat adjustments or site relocation.
    *   **Ventilation Issues:** Staff and donors affected by fumes at Masonicare at Newtown (4/9/2009) and secondhand smoke at Raymond T. Goldbach VFW Post (5/6/2009) and VFW Post 5157 (2/22/2010), with staff needing to leave due to smoke.

## Related Documents

- [483 - 2008-11-24](https://www.keypedia.com/records/483/american-red-cross-blood-services/6c362b12-5ee5-4e34-8e7e-d3c80a5e896d)

## Related Officers

- [Investigator](https://www.keypedia.com/people/anthony-n-onianwa/910dd164-8542-4259-b11f-ea3a3f6d7baa)
- [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