US FDA finds new manufacturing lapses at Eli Lilly plant

[January 20, 2024]  By Marisa Taylor and Maggie Fick

WASHINGTON (Reuters) -U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by federal investigators, according to government records obtained by Reuters.

The U.S. Food and Drug Administration inspection in July at Lilly's Branchburg, New Jersey, plant detected eight separate deficiencies. They included problems in tracking manufacturing process and quality controls, as well as lapses in its calibration of equipment and failure to properly maintain facilities and equipment, the inspection report shows.

The inspection report, which Reuters obtained through a Freedom of Information Act request, was partially redacted to remove the names of any products affected.

Lilly said in a statement to Reuters that the company had asked the FDA to allow for "additional flexibility" to manufacture migraine treatment Emgality on a different production line if needed in the future.

The FDA inspectors' visit to the plant followed that request and "resulted in some observations that were, in most cases, either addressed during the inspection or already in progress as program improvements," Lilly said. "Importantly, this situation does not affect the quality, safety or supply of any current or planned Lilly products in the marketplace."

The drugmaker said that no other products made at the facility were impacted by the inspection.

The FDA declined to comment. Other drugs produced at the plant include the widely used diabetes medicine Trulicity as well as cancer treatments Erbitux and Cyramza.

Lilly has become the world's most valuable healthcare company by market capitalization. Its shares rose 59% last year on surging demand for Mounjaro, a diabetes drug that is also a powerful obesity treatment.

The drug was approved for weight loss under the brand name Zepbound in the U.S. late last year. Lilly said in a statement that tirzepatide, the active ingredient in Mounjaro and Zepbound, was not manufactured at the Branchburg plant.

Yet the Indianapolis-based drugmaker has been cited multiple times for manufacturing problems at its U.S. plants over the last few years, Reuters has reported.

The Branchburg facility has been the subject of a U.S. Department of Justice probe following a separate Reuters story in 2021 that detailed allegations of poor manufacturing practices and data falsification.

Lilly and the Justice Department declined to comment on the status of that inquiry.

'CONCERNING' PROBLEMS

Three regulatory experts who reviewed the new inspection report described the most recent lapses as serious.

 Eli Lilly logo is shown on one of the company's offices in San Diego, California, U.S., September 17, 2020. REUTERS/Mike Blake/File Photo

"It's like whack-a-mole at this plant. The company seems to address one set of problems, only for other serious concerns to keep popping up," said Steven Lynn, a former head of the FDA's Office of Manufacturing and Product Quality.

The report described inadequate protection of electronic records detailing their manufacturing process, which could leave the company open to potential data manipulation.

Inspectors also cited inadequate training of staff who were testing samples of the drugs and examples of missing samples meant to show the stability of the medicines before their release. The company failed to address those missing samples in a timely manner, the report noted.

One particularly concerning 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, said the expert, who did not want to be named because they were not authorized to speak to media.

Former FDA official Lynn agreed the problems were "concerning," especially the issue with the electronic tracking system, which is meant to ensure "test results and other lab activities can't be changed by someone."

The three experts interviewed by Reuters said the FDA could categorize such lapses as the most serious, or "Official Action Indicated," when it responds to the inspectors' findings. The FDA declined to comment on the timing of any response.

However, the ultimate rating of the inspection could be less severe if the company was already taking "robust corrective and preventive actions" to ensure the quality of drugs made at the facility, Lynn said.

Late last year, Lilly and a former employee agreed to settle a lawsuit in which the worker claimed she was terminated after pointing out poor manufacturing practices and data falsification, according to court filings. Lilly denied the allegations.

(Reporting by Marisa Taylor in Washington and Maggie Fick in London; Additional reporting by Patrick Wingrove in New York; Editing by Michele Gershberg, Bill Berkrot and Daniel Wallis)

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