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The U.S. Food and Drug Administration (FDA) has uncovered new manufacturing oversights at Eli Lilly’s (NYSE:LLY) Branchburg, New Jersey, plant, intensifying the regulatory spotlight. Reuters reported Friday, citing government records.
The exposed inadequacies include deficient controls on electronic records stipulating the manufacturing processes, potentially triggering suspicions of data manipulation.
Adverse discoveries involve absent product samples crucial for ensuring drug stability before distribution, as disclosed by federal inspectors.
Experts interviewed by Reuters indicate that the FDA might categorize these issues as “Official Action Indicated,” the most severe classification. Nevertheless, the agency has not specified a response timeline.
Steven Lynn, a former head of the FDA’s Office of Manufacturing and Product Quality, analogized the situation to chasing targets in whack-a-mole. He said, “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.”
This occurrence follows a prior FDA investigation in July, which unearthed eight deficiencies, encompassing quality control issues, at the same facility.
According to LLY, the scrutiny arose following the company’s application for altering the production process of its migraine treatment, Emgality.
The company asserted, “The inspection resulted in some observations that were, in most cases, either addressed during the inspection or already in progress as program improvements.” Furthermore, Eli Lilly emphasized, “Importantly, this situation does not affect the quality, safety, or supply of any current or planned Lilly products in the marketplace.”
LLY is the world’s largest pharmaceutical company by market capitalization. Last year, it surpassed Johnson & Johnson (JNJ) in market leadership, attributed to its weight-loss portfolio anchored by GLP-1 drugs Mounjaro and Zepbound.
