Prior to informing regulators that the U.S. Justice Department was investigating its New Jersey facility — the plant where its COVID antibody treatment is manufactured — Eli Lilly told employees that its internal probe found no evidence of wrongdoing.
According to an exclusive Reuters report, on April 8, a group of employees at Lilly's Branchburg, New Jersey factory filed an anonymous complaint internally alleging that an executive had altered documents required by the US FDA. This launched a federal probe into alleged manufacturing irregularities and records-tampering.
Eli Lilly hired an outside law firm to investigate and in a May 20th memo to Branchburg employees, the plant manager said that the outside review did not substantiate allegations that Lilly made false statements to the FDA.
In late 2019, FDA inspectors documented numerous quality control problems at the facility in question and by March, 2020, the FDA had deemed the manufacturing issues as “Official Action Indicated,” its most serious violation. But in October 2020, the U.S. government ordered $375 million worth of Lilly’s COVID-19 antibody therapy bamlanivimab, manufactured at the Branchburg plant.