U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by federal investigators, as per the government records. The U.S. FDA inspection in July at Eli Lilly manufacturing plant at Branchburg, New Jersey, 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.
Eli Lilly manufacturing plant inspection
Eli Lilly pharmaceutical company said in a statement that the inspection followed a company request to the FDA to make a change to its manufacture of migraine treatment Emgality. Lilly did not provide details of the change.
The FDA visit “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 FDA declined to comment.
Eli Lilly pharmaceutical company products
Other drugs produced at the Eli Lilly plant include the widely used diabetes medicine Trulicity as well as cancer treatments Erbitux and Cyramza.
Eli Lilly pharmaceutical company has become the world’s most valuable healthcare company by market capitalization. Eli Lilly’s shares rose 59% last year on surging demand for Mounjaro, a diabetes drug that is also a powerful obesity treatment. The Eli Lilly diabetes drug was approved for weight-loss under the brand name Zepbound in the U.S. late last year.
U.S. Department of Justice probe in 2021
The Eli Lilly plant at Branchburg has been the subject of a U.S. Department of Justice probe following a report 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.
Three regulatory experts who reviewed the new inspection report described the most recent lapses in Eli Lilly products as serious.
“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 inspection report, which Reuters obtained through a Freedom of Information Act request, was partially redacted so it was not possible to determine which drugs might have been affected.
Poor manufacturing practices
The report described inadequate protection of electronic records detailing their manufacturing process, inadequate training of staff who were testing samples of the drugs.
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.
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 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.
