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The U.S. Food and Drug Administration (FDA) has found new manufacturing lapses at Eli Lilly’s (NYSE:LLY) Branchburg, New Jersey, plant, which has already been under regulatory scrutiny, Reuters reported Friday, citing government records.
The findings include insufficient controls on electronic records detailing the manufacturing procedures, which could raise concerns about potential data manipulation.
The federal inspectors have also found instances of missing product samples used to ensure drug stability before distribution.
According to experts interviewed by Reuters, in its response to the findings, the FDA could classify the issues as the most serious, or “Official Action Indicated. The agency has yet to disclose a timeline for its response.
“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,” Steven Lynn, a former chief of the FDA’s Office of Manufacturing and Product Quality, said.
The plant was the subject of a previous FDA inspection in July, which led to findings of eight defects, including issues related to quality control.
According to LLY, the inspection came in response to the company’s request to get approval for a change in the production of its migraine treatment, Emgality.
The visit “resulted in some observations that were, in most cases, either addressed during the inspection or already in progress as program improvements,” the company added.
“Importantly, this situation does not affect the quality, safety, or supply of any current or planned Lilly products in the marketplace.”
Eli Lilly’s (LLY) is the world’s biggest drug maker in terms of market capitalization. Last year, it claimed the top spot, dethroning Johnson & Johnson (JNJ) thanks to its weight-loss franchise, dominated by GLP-1 drugs Mounjaro and Zepbound.
