Company: South Texas Blood and Tissue Center
Product: Blood facility
Date: 7/17/03
Your facility failed to check input to and output from its computer and related systems for accuracy [21 CFR 211.68(b)]. For example,
Your facility’s _____ computer system and _____ lacked controls or procedures to prevent improper sample analysis or mix-ups. As explained above (1.a), your facility retested a unit of source plasma in _____ two separate times, on two different days using two different instruments, and obtained opposite results. Your facility reported both discrepant results to the blood manufacturer that had collected the unit. Your facility should have established controls to ensure that one unit would not be retested in duplicate more than once, and to ensure that your facility would not report discrepant testing results to a manufacturer.
Your facility did not evaluate the _____ computer system to assure its proper performance before your facility implemented that system in 2001. Until November 2002, your facility used that system during the donor deferral process to verify medications that affect blood collection. When too many personnel use this system, it converts to a status that renders it inoperable. As a result, your facility had to conduct 4 recalls between July 2002 and October 2002 for donors who were improperly accepted for donation due to their medication status because this instrument malfunctioned.
FDA District: Dallas District Office
