More than a year after Eli Lilly received a subpoena centered on quality control snafus and alleged document tampering in New Jersey, U.S. drug inspectors have turned up a fresh batch of problems at the same site.
The U.S. FDA has logged multiple new quality control lapses at Lilly’s plant in Branchburg, New Jersey, Reuters first reported, citing an agency report seen by the news outlet.
Problems at Branchburg stretch back to at least 2020, when the FDA cited Lilly on two counts of inadequate “control of computer systems," a Lilly spokesperson said at the time.
Those two findings included deleted data on the company's manufacturing processes and failed quality control for audit paper trails, sources told Reuters at the time.
Last May, meanwhile, Reuters reported employees at the site accused an executive of altering FDA-required documents in a bid to downplay serious quality control problems.
Several weeks after that, the Department of Justice handed down a subpoena linked to the Branchburg site, which had been producing doses of Lilly’s COVID-19 antibody treatment.
This past summer, FDA inspectors returned to the plant for a 12-day inspection, where they found Lilly workers did not adequately track potentially contaminated drug batches meant to be inspected by the company’s quality control unit, Reuters reported this week. The inspection yielded a Form 483, which the news service says it obtained through a Freedom of Information Act request.
The FDA report didn’t say whether the medicines in question ultimately went to market. The drug batches flagged in the report included those for Lilly’s diabetes med Trulicity as well as its migraine therapy Emgality and its cancer drugs Erbitux and Cyramza.
Eli Lilly did not immediately respond to Fierce Pharma’s request for comment on the latest inspection update. The company told Reuters it has "rigorous quality systems in place to ensure compliance with stringent regulatory requirements."
Meanwhile, Lilly is defending its actions at Branchburg on multiple fronts. Earlier this summer, whistleblower Amrit Mula—who was fired by Lilly more than three years back—filed suit against the Indianapolis-based pharma giant, arguing her dismissal was a result of reporting manufacturing problems at the plant.
Mula, a former HR officer at Lilly, says she witnessed and reported Lilly employees failing to comply with FDA-mandated standard operating procedures. She also alleges staffers failed to report contamination, improperly disposed caustic substances into waterways and falsified quality assurance testing documents.
“Lilly continues to deny these allegations and looks forward to the opportunity to defend itself in court," the company said in a statement in response to that lawsuit.