FDA 483 - The American National Red Cross - April 25, 2008

The FDA inspection of this firm revealed multiple deficiencies in its quality system and adherence to regulatory requirements for blood and blood components.

**Observation 1** details failures in promptly and adequately investigating, correcting, and preventing recurrence of problems. Examples include: * A February 23, 2007, problem regarding incomplete/incorrect donor records (Apheresis Donor Continuous Record) had a failed effectiveness check, but no follow-up or re-evaluation of the corrective action occurred as of April 17, 2008. * An investigation initiated on January 24, 2008, for a trend of incomplete/incorrect/unreviewed Apheresis Alarm Logs was not completed by April 17, 2008. * An employee's third instance of documenting an illogical donor temperature on December 31, 2007, resulted in verbal counseling, despite the corrective action requiring written counseling for a third offense.

**Observation 2** highlights the firm's failure to notify consignees and/or FDA's Baltimore District Office within 48 hours of distributing unsuitable blood or blood components. Specific instances include: * Twenty-six RBC units, incorrectly stored and then distributed on March 20, 2007, lacked the required 48-hour notification to FDA. * Fresh frozen plasma components failing manufacturing timeframe requirements, discovered December 8,