The company reported the development in a statement to shareholders on Thursday [May 27].
Indiana headquartered, Lilly, did not disclose anything further about the nature of the investigation, but the pharma giant said it was cooperating fully in the matter.
The probe was launched by the DOJ on the basis of the pharma company’s alleged manufacturing and records violations at the Branchburg plant, according to a Reuters report.
That New Jersey facility produces Lilly’s Covid-19 monoclonal antibody drug, bamlanivimab, among others.
Lilly employees had allegedly accused an executive at that manufacturing site of altering FDA-required documents in an effort to downplay serious quality control problems, claimed the Reuters piece.
Own review
In its disclosure to investors last week to the US Securities and Exchange Commission (SEC), Lilly said it had previously engaged external counsel to conduct an independent investigation of certain allegations relating to the Branchburg plant.
The company stressed it is “deeply committed to manufacturing high-quality medicines” and that “the safety and quality of our products is our highest priority.”
Separately, an FDA team, as part of inspections run in March this year, identified manufacturing problems at another Lilly site in Indianapolis, a facility that bottles bamlanivimab and other drugs, again reported Reuters, adding that the issues included alleged substandard sanitation and quality control issues.
Lilly's bamlanivimab was the first neutralizing monoclonal antibody to receive EUA from the FDA – in November 2020 - as a treatment for mild to moderate COVID-19. More than 400,000 US patients have been treated with it. The COVID-19 antibody drug is now combined with a second Lilly drug, called etesevimab, to treat patients. The pairing of both drugs neutralizes more of the emerging COVID-19 variants in the US than bamlanivimab alone said Lilly in April.
