Earlier this month, Eli Lilly’s COVID-19 drug factory in New Jersey garnered unwanted headlines for quality control snafus and alleged document tampering. Now, the Department of Justice (DOJ) has stepped in to investigate.
Thursday, Lilly revealed the DOJ has issued a subpoena demanding documents relating to the site in Branchburg, New Jersey. The site produces doses of Lilly's COVID-19 antibody treatment, which has recently faced setbacks for its susceptibility to certain variants.
Meanwhile, Lilly says it's working with outside counsel on an independent investigation. Lilly is "cooperating fully" with the DOJ probe, the company said in a Securities and Exchange Commission filing.
“Lilly is deeply committed to manufacturing high-quality medicines for patients who need them, and the safety and quality of our products is our highest priority,” the drugmaker said in the filing. A Lilly spokesperson told Fierce Pharma that the company couldn't comment further.
In early May, Reuters reported that employees at the site accused an executive of altering FDA-required documents in an effort to downplay serious quality control problems, citing an internal complaint and a source familiar with the matter