Officials found problems with tracking quality controls, lapses in facility and equipment maintenance, and equipment calibration issues at Lilly's plant in Branchburg, New Jersey.
According to an exclusive Reuters report, a recent inspection by FDA officials found several new discrepancies at drugmaker Eli Lilly's Branchburg, New Jersey manufacturing facility.
According to an inspection report obtained by Reuters through a Freedom of Information Act request, the FDA identified eight manufacturing issues at the Branchburg location. These include problems with the manufacturing process and quality control tracking and failure to maintain equipment and facilities.
The drugs impacted by the inspections were removed from the report.
In a statement to Reuters, Lilly says the company had asked the FDA to allow for additional flexibility to manufacture Emgality — a migraine drug — on a different production line. The request led to an FDA inspection, which "resulted in some observations that were, in most cases, either addressed during the inspection or already in progress as program improvements. Importantly, this situation does not affect the quality, safety or supply of any current or planned Lilly products in the marketplace."
The company told the news outlet that no other drugs were affected by the inspection.
Lilly makes Trulicity, a diabetes medication, cancer treatments such as Erbitux and Cyramza, and the highly popular diabetes and obesity drugs Mounjaro and Zepbound. However, Lilly said the active ingredient in Mounjaro and Zepbound is not manufactured at the Branchburg plant.
In September 2023, Lilly settled a lawsuit brought forth by former employee Amrit Mula, who claimed the company terminated her after pointing out discrepancies at the Branchburg location, including poor manufacturing processes and data falsification. The lawsuit asserts that these shortfalls involved several biologic drugs and Lilly's Trulicity.
Mula's claims, reported by Reuters in 2021, resulted in a U.S. Justice Department probe into the allegations. However, the status of that investigation is unknown.