# FDA 483 - American Red Cross Blood Services Great Lakes Region - April 27, 2010

Source: https://www.keypedia.com/records/483/american-red-cross-blood-services-great-lakes-region/7cc24bbe-3334-43cd-8fc3-afa6630cf9c5

> FDA 483 for American Red Cross Blood Services Great Lakes Region on April 27, 2010. Product: N/A. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: American Red Cross Blood Services Great Lakes Region
- Inspection Date: 2010-04-27
- Office Name: Detroit District Office
- Summary: This FDA Form 483 was issued to the American National Red Cross Great Lakes Region, a blood bank located at 1800 E Grand River Ave, Lansing, MI 48912-2305. The inspection was conducted by Investigator Kelley L Clark from April 5, 2010, to April 27, 2010.

Two observations were made:

1.  **Failure to perform a thorough investigation of a lot or unit's failure to meet specifications:** Specifically, Exception Report E-0632596 (I-0003622) regarding an employee not performing a 30-second arm scrub before phlebotomy, failed to consider frozen red blood cells (pcode 06200) as potentially affected. This led to a failure to recall unit #18FZ24606, which was shipped to a customer on November 29, 2002, as required by written procedure #11.2.002, Directive: Management of Suspect Products. The cMRB decision to recall transfusable components from 09/17/2001 to 08/10/2009 did not include frozen red blood cells.

2.  **Inadequate investigation of reported adverse reactions:** Medical Director reviews of Donor Reaction and Injury Records (DRIR)

## Related Documents

- [483 - 2008-03-21](https://www.keypedia.com/records/483/american-red-cross-blood-services-great-lakes-region/335e82a1-12ee-4c33-ae2a-e168510a0789)

## Related Officers

- [Kelley L. Clark](https://www.keypedia.com/people/kelley-l-clark/2e3e826d-698b-46a2-8554-260cb9e87a74)

Company: https://www.keypedia.com/companies/american-red-cross-blood-services-great-lakes-region/7b094ca2-76ec-4f0c-9636-0402a8dbe423

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03