Eli Lilly manufacturing plant under FDA scrutiny for quality control issues
Manufacturing problems, including failure to properly maintain facilities and equipment, were discovered at Lilly's New Jersey plant during an FDA inspection, as the drugmaker’s weight-loss medication Zepbound is in high demand.
The U.S. Food and Drug Administration found eight separate manufacturing problems at an Eli Lilly plant in Branchburg, N.J., during an inspection last summer. The inspection report, obtained by Reuters under a Freedom of Information Act request, cited problems in tracking manufacturing processes and quality controls; lapses in equipment calibration; and failure to properly maintain facilities and equipment.
The FDA inspection “resulted in some observations that were, in most cases, either addressed during the inspection or already in progress as program improvements,” the company said. “Importantly, this situation does not affect the quality, safety or supply of any current or planned Lilly products in the marketplace.”
The report was partially redacted to remove the names of affected products. Lilly said it had asked the FDA to allow for “additional flexibility” to manufacture its migraine treatment Emgality on a different production line if needed in the future. Other drugs produced at the New Jersey plant include the widely used diabetes medication Trulicity, as well as cancer treatments Erbitux and Cyramza. The report comes as Lilly has become the world’s most valuable health-care company by market capitalization, in part because of strong demand for its weight-loss medication Zepbound (which is not manufactured at the New Jersey plant).
Lilly has been cited multiple times for manufacturing problems at its U.S. plants in recent years, Reuters reported. The Branchburg plant has been the subject of a U.S. Department of Justice probe following a separate story in 2021 that included allegations of poor manufacturing practices and data falsification.
The inspection report described inadequate protection of electronic records detailing manufacturing processes, which could leave the company open to potential data manipulation. Inspectors also cited inadequate training of staff who were testing drug samples and examples of missing samples meant to show the stability of the medicines before their release. The company failed to address these missing samples in a timely manner, the report noted. One finding suggested neglect of equipment and the facility overall, said one of the experts, a government official with knowledge about such manufacturing issues. For instance, the inspectors noted discoloration of a container used to purify the active ingredient of drugs, which could lead to contamination, the expert said.
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Former FDA official Steven Lynn said the problems are “concerning,” especially the issue with the electronic tracking system, which is meant to ensure that test results and other lab activities can’t be changed. “It’s like Whac-A-Mole at this plant,” he said. “The company seems to address one set of problems, only for other serious concerns to keep popping up.”