American National Red Cross, National Testing Lab – FDA 483, Jun 16, 2010

On June 16, 2010, the FDA issued a Form 483 to American National Red Cross, National Testing Lab, a blood bank located at 100 Eliot Street, Detroit, MI 48201-2408, following an inspection from May 25 to June 16, 2010. The inspection identified two observations.

**Observation 1:** Annual competency reviews and/or quality assurance process reviews of operators did not effectively identify steps not being correctly performed according to work instructions, package inserts, or operator's manuals. * **Specific Issues:** * Personnel performing reagent additions were not gently inverting rare reagents as directed by work instructions and package inserts for approximately two years. Competency reviews failed to identify this, with no personnel failing. * Employees performing purge solution preparation and loading on a specific instrument (VTL Modulo) were not replacing the cap assembly as required by the user's manual and work instructions for approximately two years. This was identified by exception report E-0796638. Competency assessments, which included this step, did not result in any failures. Quality process reviews in 2009 in the VTL laboratory indicated this step was understood, despite the ongoing issue.

**Observation 2:** Failure to adequately investigate and correct a problem. * **Specific Issue:** A quality control supervisor'