483
Company: American Red Cross
City and Sate: Baltimore, MD
FDA District: Baltimore, MD
Dates of Inspection: 4/22-6/21/02
4. Failure of the quality control unit to determine root cause and prevent recurrence of significant deviations related to BSD 73.200M, “Shipping” version 1.7 January 2001. Between October 22, 2001 and April 23, 2002, the Chesapeake Region recorded 20 LCTs involving shipping of 28 components physically, but not electronically. In that BSD 92.103T, “Deviations” version 1.1 April 2001 does not require a root cause analysis or implementation of preventative action for deviations that are classified as LCTs, no action was taken by the Chesapeake Region to determine root cause and prevent recurrence until April 26, 2002, when FDA investigators discussed their concerns about such deviations. On April c29, 2002, the Chesapeake Region implemented the requirement for a second party manual implementation of the corrective action. [Handwritten annotation: “STET NLR 6/21/02 GJO 06212002”]
11. a) BSD 73.200M, “Shipping” version 1.7 January 2001, which requires that blood components be “shipped using the computer system,” and that the number of components in a shipping container be physically counted to ensure consistency with the number of components listed on the related packing slip. FDA’s review of log, correct, trend (LCT) records for the period October 22, 2001 through May 31, 2002 revealed that 33 blood components were shipped to consignees physically, but not electronically. Shipment of blood components physically, but not electronically, results in no record of final component disposition and failure to perform a final component suitability check for components manufactured in the shipping region. For example, the following components were shipped physically but not electronically:
b) FDA’s review of lost product deviations for the period, October 1, 2000 through May 31, 2002 found 18 lost blood components were reported to Biomedical Headquarters. On April 3, 2001, Biomedical Headquarters issued BSL 01-061,, “Update for Measuring Acceptable Quality Limit (AQL) for Components Without Final Computer Disposition (CWOFCD),” which establishes an AQL of less than 1.004% of total products handled each calendar quarter. The BSL does not require Blood Service Regions to investigate or take any action prevent recurrence of lost products unless their individual monthly rate is equal to or greater than 0.004%, or if a region has an upward trend for three consecutive months. For example, the following blood components were lost and recorded as LCTs, which require no root cause analysis or preventative action:
i) WBN [REDACTED] (product cod 04710, AS1 red blood cell, leukoreduced), was unaccounted for during daily inventory reconciliation of on December 27, 2001. The component was confirmed as a lost product and moved electronically on January 28, 2002 to Component Reconciliation Tracking Center (CRTC), which is an electronic location for lost products.
ii) WBN [REDACTED] (product code 19601, recovered plasma > 24 hours) was not located during inventory reconciliation on October 10, 2001. The loss was discovered during supervisory review of reconciliation records on November 12, 2001. The component remained lost and was moved electronically to CRTC on November 23, 2001.
13. Failure to validate that 19 Pre-Check devices can be downloaded off the pre-check workstation at the same time. Validation was performed to download only one Pre-Check device at a time. The document “Test Procedures for the Access Specialty Equipment,” NBC-DI-00002271-2.1.0, dated 4/3/98, pg. 3-17, documents that Test Case #6, Pre-Check Workstation, was validated by connecting the DB25 end of the serial cable to the pre-check unit and the DB9 end to the pre-check workstation and turn on the Pre-Check device. BSD 22.101T, Pre-Check Computer Operations, Version 4/15/94, effective dated 9/11/36, documents on page 11, “connect the handheld computers to the multi-port cable by connecting the first handheld computer to fully pinned ‘terminating’ connector, the most remote port on the multi-port cable from the PC port. Then connect the other handheld computers to any of the other ports.”
