Cardinal Health 414 LLC - May 15, 2009

Your quality control unit failed to adequately investigate sterility failures of three (3) released batches of FDG F-18 injection manufactured between 12/17/08 and 1/16/09. Your firm concluded in all investigations that the product batches were sterile based upon negative re-test results and the conclusions that the same operator contaminated the samples when he inoculated the media tubes. The investigation lacked scientific evidence to support the conclusions that the media was contaminated by the operator. Your corrective action was limited to re-training of the operator on aseptic techniques and the written procedure.