BLOOD & BIOLOGICS.

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Cangene, Winnipeg, Manitoba, Canada, Sept. 22 (Los Angeles). The agency inspected the firm's subsidiary in Van Nuys, CA, Serex International, and wrote that an employee "was unable to use the equipment required" to perform a review of prior donations. FDA also hit Serex for written procedures that did not require reviews of donor's histories to determine eligibility. The unnamed investigators inspected Serex June 26-29 and July 5.

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Community Blood Bank of the Lancaster County Medical Society, Lincoln, NE, Oct. 19 (Kansas City). The letter stated that the blood bank had shipped components from a unit of blood that had not been "tested per manufacturer's instructions" for hepatitis B surface antigen (HBsAg). FDA also cited the blood bank for failure to follow SOPs for a test for HBsAg that resulted in "an unexpected reactive" for which personnel voided the test, tested again and recorded the results of the second test as those from a first. The agency commented that Community generated no report for this deviation and cited the blood bank for an SOP that did not "describe the current method of deferring donors who have experienced red blood cell loss." The agency wrote that the duplicate donor identification system procedure failed to describe the factors to be considered in excluding potential duplicate donors and noted two instances in which Community failed to identify an apparent duplicate donorship of two units of red blood cells. FDA acknowledged the firm's September response to the 483 stated that corrections would be verified in a subsequent inspection. The inspec-tion took place Aug. 28-Sept. 1.