The U.S. Food and Drug Administration (FDA) has uncovered new manufacturing issues at Eli Lilly’s plant in Branchburg, New Jersey

The U.S. Food and Drug Administration (FDA) has uncovered new manufacturing issues at Eli Lilly’s plant in Branchburg, New Jersey, as per government records obtained by Reuters. The FDA inspection in July revealed eight deficiencies, including problems in tracking manufacturing processes, quality controls, equipment calibration, and facility maintenance. The inspection report, obtained through a Freedom of Information Act request, has some redactions. Eli Lilly stated that the issues raised during the inspection were either addressed or in progress as program improvements and assured that it doesn’t impact the quality, safety, or supply of their products. The plant produces various drugs, including the diabetes medicine Trulicity and cancer treatments Erbitux and Cyramza. The Branchburg facility has been under investigation by the U.S. Department of Justice following allegations of poor manufacturing practices and data falsification. Regulatory experts consider the recent lapses serious, highlighting concerns such as inadequate protection of electronic records and neglect of equipment and facility maintenance. The FDA’s response to the inspection findings is awaited, and the ultimate rating may depend on the company’s corrective actions. Eli Lilly, the world’s most valuable healthcare company by market capitalization, has faced manufacturing issues at its U.S. plants in recent years.