Healthcare Giant Eli Lilly Under FDA Lens Again For Manufacturing Lapses

Eli Lilly And Co LLY faces renewed scrutiny as the FDA inspectors reveal additional manufacturing issues at its Branchburg, New Jersey plant. 

In a recent inspection conducted by the FDA in July, eight deficiencies were identified, ranging from problems in tracking the manufacturing process to lapses in equipment calibration and facility maintenance.

The FDA inspection, prompted by Eli Lilly’s request for a change in the manufacture of migraine treatment Emgality, raised concerns about the overall quality control at the Branchburg facility. 

Also Read: Eli Lilly’s Blockbuster Diabetes Drug Mounjaro Set To Enter New Markets Amid Manufacturing Boost.

Notably, other widely used drugs, such as diabetes medicine Trulicity and cancer treatments Erbitux and Cyramza, are also produced at this plant.

Reuters noted Eli Lilly’s response to the findings, stating that the observations made during the inspection were either addressed on-site or were already part of ongoing improvement programs. 

Despite being the most valuable healthcare company by market capitalization, Eli Lilly has faced multiple citations for manufacturing issues at its U.S. plants in recent years. 

The Branchburg facility, specifically, is under investigation by the U.S. Department of Justice following allegations of poor manufacturing practices and data falsification reported by Reuters in 2021.

Reviewing the new inspection report, regulatory experts express serious concerns, likening the recurring problems at the Branchburg plant to a game of “whack-a-mole.” 

The report highlighted issues such as inadequate protection of electronic records, insufficient staff training, and neglect of equipment and facility maintenance.

The experts caution that the FDA may categorize these lapses as “Official Action Indicated,” indicating the most severe level of concern. However, the severity could be mitigated if Eli Lilly promptly demonstrated robust corrective and preventive actions.

In September, a federal judge in Massachusetts overturned a $176.5 million jury verdict against Eli Lilly. 

The verdict, which had favored Teva Pharmaceutical TEVA, had found that Lilly’s migraine drug, Emgality, infringed upon three patents related to Teva’s rival drug, Ajovy.

Price Action: LLY shares are up 0.45% at $626.18 on the last check Friday.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

Photo by rafapress on Shutterstock