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Lilly

Executive Summary

Company expects no shortage of U.S. supplies of products manufactured from its Sesto Fiorentino Italy plant that was the subject of a May 28 FDA warning letter. During a February 1-5 inspection, the agency found deficiencies in both aseptic processing areas and media fill procedures. The Lilly plant manufactures Mandol (cefamandole nafate), Keflin (cephalothin sodium), Ketzol (cefazolin sodium) and Kefurox (cefuroxime sodium)
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PS034368

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