Overland Park Regional Medical Center, Overland Park, KS, July 16

Warning Letter Bulletin, August, 2007

During an inspection of the blood bank, FDA documented numerous deviations from the GMP regulations, including failure to adequately provide for identification and handling of all test samples so that they are accurately related to the specific unit of product being tested and to the specific recipient.

Another deviation included the failure to prepare and maintain written reports of investigations of adverse reaction, including conclusions and follow up according to SOP. Specifically, the firm failed to thoroughly evaluate and investigate recipient transfusions reactions.

Finally, the inspection revealed that there was a failure to make and record a thorough investigation, including conclusion and follow-up; of any unexplained discrepancy or the failure of a unit or lot to meet specifications and to extend the investigation to other products that may have been associated with the discrepancy or failure.

The letter stated in detail:

* Investigation Summary dated 5/11/06 has no documented evidence of an investigation concerning an incorrectly entered antibody screen.

* Investigation Summaries dated 4/27/06 and 5/17/06 has no actions taken concerning incorrect reporting of blood types.

FDA added that it received the company's response addressing the initial steps to correct the deviations noted. However, the response does not address any underlying problems which may be causing the deviations.

Also, the response does not provide "assurance to FDA that you have taken effective measures necessary to prevent recurrence of the deviations." AE; QC/QS; 14219W