Incomplete records for all blood components produced; failure to routinely review error messages on computer system.
The inspection also revealed that _____ error messages on your computer system are not routinely reviewed, processed, and investigated to determine final disposition. The instructions for computer system training do not include a clear written explanation of what error messages are and what the user is supposed to do when an error message is en countered. No written procedures are established for the review, processing, and final disposition of error messages. In addition, your written procedures for computer validation do not include clear explanations of what to do when risk analysis weights fall between 0 to 9, how QA will perform validation review before and after testing, what the I/S Systems Manager is to review and how to perform the review, or when and how to document live system checks after testing on the training system.
We acknowledge receipt of your March 9, 1999 letter submitted in response to the Inspectional Observations (Form FDA 483) issued at the close of the inspection, addressing the listed observations and stating corrective actions taken. The corrective actions stated in your response concerning the computer system observations appear adequate. However, your response fails to adequately address the final dispositions of the twenty-one unaccounted for blood components specified above, including the unsuitable plasma component separated from blood unit #337264 which tested repeatedly reactive HIV 1-2. This response provides no assurance that a thorough investigation has been made to determine the disposition of these and possibly other unaccounted for blood components produced by your blood bank and does not alleviate our concerns.
