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

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)