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)
You may also be interested in...
GMP Compliance Guidances Should Be Increased, Lilly’s Miner Says
FDA needs to issue more guidances on GMP compliance topics, Lilly Corporate GMP Compliance Leader David Miner, PhD, said
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011