Eli Lilly faces FDA crackdown for manufacturing issues at plant handling COVID-19 antibody by Kyle Blankenship <https://www.fiercepharma.com/author/kyle-blankenship> | Oct 14, 2020 9:29am https://www.fiercepharma.com/manufacturing/eli-lilly-hot-water-fda-for-manufacturing-issues-at-plant-handling-covid-19-antibody [image: Eli Lilly] Eli Lilly submitted COVID-19 antibody LY-CoV555 for the FDA's emergency use nod last week. (Eli Lilly) Share <https://www.addtoany.com/share#url=https%3A%2F%2Fwww.fiercepharma.com%2Fmanufacturing%2Feli-lilly-hot-water-fda-for-manufacturing-issues-at-plant-handling-covid-19-antibody&title=Eli%20Lilly%20faces%20FDA%20crackdown%20for%20manufacturing%20issues%20at%20plant%20handling%20COVID-19%20antibody> Facebook <https://www.fiercepharma.com/#facebook>Twitter <https://www.fiercepharma.com/#twitter>LinkedIn <https://www.fiercepharma.com/#linkedin>Email <https://www.fiercepharma.com/#email>Print <https://www.fiercepharma.com/#print>
Just days after Eli Lilly sent an COVID-19 antibody ahead for FDA scrutiny, the drugmaker's immediate chances were halted by a damaging trial stop for the therapy. Now, the FDA has knocked Lilly for its manufacturing controls at a New Jersey site producing the antibody. The FDA cited Lilly's Branchburg, New Jersey facility on two counts of inadequate "control of computer systems," Lilly confirmed in an email. Those two findings included deleted data on the company's manufacturing processes and failed quality control control over audit paper trails, sources told <https://in.reuters.com/article/health-coronavirus-elililly-idINKBN26Z0CH> Reuters. While Lilly assured that the flaws weren't tied to its production of COVID-19 antibody LY-CoV555, which is produced on site, the drugmaker could run into issues snaring an emergency use authorization for the therapy based on those findings. *Click on the link for the rest.* --- Support News from Underground: http://bit.ly/NFUSupport Visit News from Underground: https://markcrispinmiller.com You received this email because you are subscribed to News from Underground. To unsubscribe from this email list, please go to: http://www.simplelists.com/confirm.php?u=pIdjNUgiG2h8yxbhC54SSy4SEskAoEMs For archives, please go to: http://archives.simplelists.com/nfu
