FDA 483 - American National Red Cross Blood Services SW Region - August 09, 2010

During an inspection from July 26, 2010, to August 9, 2010, the FDA observed deficiencies at the American National Red Cross SW Region facility located at 10151 E 11th St, Tulsa, OK 74128-3005. The inspection, conducted by Investigator Janice M. Hickok, identified one primary observation: recall records for distributed product were incomplete.

Specifically, for a recall initiated on February 12, 2010, involving 25 B positive units from import session 62843 that were left out of controlled storage for over 30 minutes, the firm failed to maintain complete product dispositions. Five Whole Blood Numbers (WBNs) (001Q35750, 001LP04986, 001LP04983, 001LH00108, and 001GL53602) lacked product dispositions, and a required second notification to the consignee was not sent. Per SOP 11.3.011 Version 1.5, a final notification letter should have been sent by April 3, 2010, but was delayed until July 28, 2010.

Additionally, two WBNs (001Q357