The U.S. Department of Justice is digging deeper into quality concerns related to an Eli Lilly manufacturing plant.
This week, the company reported that the DOJ has subpoenaed the company for documents connected to a plant in New Jersey responsible for producing a COVID-19 treatment, bamlanivimab.
According to a Reuters report from earlier this month, employees have accused an executive at the facility of destroying FDA-required documents to hide serious quality lapses at the plant.
It wasn’t the facility’s first run-in with suspicious quality control issues: Earlier this year, Reuters reported that a former human resources officer tasked with investigating manufacturing issues has accused the company of destroying or falsifying documents related to quality issues.
Ultimately, an FDA inspection at the plant revealed several quality problems, including a failure to properly investigate issues related to the production of the company’s blockbuster Trulicity, resulting in an Official Action Indicated in 2019.
The company has since hired an independent consultant to help with compliance issues at the plant.
