An employee complaint at Eli Lilly's Branchburg plant alleges altered quality control docs amid FDA probe — report
Eli Lilly was one of the earliest players in the race for a Covid-19 antibody, but a series of setbacks at a New Jersey manufacturing site have set back its efforts. Now, an internal complaint reportedly claims that a director at that site knowingly fudged quality control docs right under the FDA’s nose.
An employee complaint from Eli Lilly’s manufacturing plant in Branchburg, NJ, alleged that a director altered documents handed over to FDA regulators as part of an effort to downplay serious quality control issues amid the agency’s probe at the site, Reuters reported.
The FDA has been investigating the Branchburg location, which produces Covid-19 antibody bamlanivimab, after issuing a two-observation Form 483 in August that faulted the site for inadequate quality and laboratory controls. An unnamed source told Reuters those quality concerns have continued despite the FDA’s focus, leading to the April 8 complaint that management is fudging its results.
The exact dates and details of the complaint weren’t reported. A Lilly spokesperson could not be reached for comment by press time.
In addition to the renewed concerns at the Branchburg site, Reuters reported the FDA has identified issues at Lilly’s Indianapolis fill-finish plant as well, including “substandard sanitation and quality control procedures.”
After racing out to a lead in the race for a Covid-19 antibody, Lilly has faced a series of setbacks as the FDA pulled its initial EUA for solo bamlanivimab last month, citing the rise in variants. Lilly was already facing a meager market for the antibody and middling results in treating hospitalized patients. Lilly still sports an EUA for an antibody combo that contains bamlanivimab, but other drugmakers are aiming for more broadly neutralizing antibodies that can stand up to variants.
The Branchburg plant has been the focus of a lot of the scrutiny around Lilly’s manufacturing of the antibody. Back in March, Reuters reported that a top human resources employee at the site claimed she was fired after working to blow the whistle on quality issues at the site. Among the many complaints cited there, the employee claimed the Branchburg site had a history of documents go missing, with employees often sent to dig through the trash to find them.
Meanwhile, questions about Lilly’s leadership up to the very top has been called into question recently. In February, the drugmaker ousted CFO Josh Smiley after it verified claims he had engaged in inappropriate communications with an employee. Smiley was one of the handpicked deputies of CEO David Ricks, who came over to Lilly in 2017 to help right the ship on a flagging pipeline.