Government records obtained by a news agency reveal that US inspectors have discovered fresh manufacturing issues at an Eli Lilly plant that has been the subject of federal investigation.
In July, an inspection conducted by the U.S. Food and Drug Administration at Lilly’s Branchburg, New Jersey, plant uncovered a total of eight deficiencies. The inspection report reveals a range of issues, including difficulties in tracking the manufacturing process and quality controls. It also highlights lapses in equipment calibration and failure to adequately maintain facilities and equipment.
An inspection report, obtained by a news agency through a Freedom of Information Act request, has been partially redacted to protect the privacy of the products involved.
Lilly has officially requested the FDA to grant them “additional flexibility” in the production of their migraine treatment, Emgality. The company aims to have the option to manufacture the medication on a different production line if necessary in the future, according to a statement provided to a news agency.
During their visit to the plant, FDA inspectors made some observations which were either addressed during the inspection or were already being worked on as program improvements, according to Lilly. “It is crucial to note that this situation has no impact on the quality, safety, or availability of any existing or upcoming Lilly products in the market.” No other products manufactured at the facility were affected by the inspection, according to the drugmaker.
The FDA declined to comment. Additional medications manufactured at the facility include the highly prescribed diabetes drug Trulicity, along with cancer therapies Erbitux and Cyramza.
Lilly has emerged as the leading healthcare company in terms of market capitalisation on a global scale. Shares of the company experienced a significant increase of 59% in the past year, driven by the growing demand for Mounjaro, a highly effective drug for diabetes and obesity.
Last year, the U.S. approved a drug called Zepbound for weight loss. In a statement, Lilly confirmed that tirzepatide, the active ingredient found in Mounjaro and Zepbound, was not produced at the Branchburg plant.
According to a news agency, the Indianapolis-based drugmaker has faced multiple citations for manufacturing problems at its U.S. plants in recent years.
The Branchburg facility is currently under investigation by the U.S. Department of Justice. This investigation comes after a news agency published a story in 2021, which exposed allegations of poor manufacturing practices and data falsification. Lilly and the Justice Department have not provided any comments regarding the current status of the inquiry.
Concerning’ Problems
According to three regulatory experts, the most recent lapses highlighted in the inspection report are being considered as serious.
“The situation at this plant resembles a game of whack-a-mole.” “The company appears to tackle a specific set of issues, only to be confronted with other significant concerns,” stated Steven Lynn, a former leader of the FDA’s Office of Manufacturing and Product Quality.
In a recent report, it was highlighted that the company’s electronic records detailing their manufacturing process are not adequately protected. This raises concerns about the potential for data manipulation and the company’s vulnerability to such risks.
Inspectors have highlighted concerns regarding the insufficient training provided to staff responsible for testing drug samples. Additionally, they have found instances where samples meant to demonstrate the stability of medicines were missing prior to their release. According to the report, the company did not address the issue of the missing samples promptly.
According to a government official familiar with manufacturing issues, one of the experts expressed concern over a troubling finding that indicated neglect of equipment and the facility as a whole.
An expert, who preferred to remain anonymous due to lack of authorization, reported that during an inspection, discoloration was observed on a container utilized for purifying the active ingredient of drugs. This discoloration has the potential to cause contamination.
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.”
According to three experts interviewed by a news agency, the FDA may classify these lapses as the most serious, or “Official Action Indicated,” in its response to the inspectors’ findings. The FDA has chosen not to provide any comment regarding the timing of their response.
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