FDA finds new manufacturing lapses at Eli Lilly plant

 U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by federal investigators, according to government records obtained by Reuters.

The U.S. Food and Drug Administration inspection in July at Lilly's Branchburg, New Jersey, plant 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.

Lilly said in a statement to Reuters 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. Other drugs produced at the plant include the widely used diabetes medicine Trulicity as well as cancer treatments Erbitux and Cyramza.

Lilly has become the world's most valuable healthcare company by market capitalization. Its shares rose 59% last year on surging demand for Mounjaro, a diabetes drug that is also a powerful obesity treatment.

The drug was approved for weight loss under the brand name Zepbound in the U.S. late last year. Lilly said in a statement that tirzepatide, the active ingredient in Mounjaro and Zepbound, was not manufactured at the Branchburg plant.

Yet the Indianapolis-based drugmaker has been cited multiple times for manufacturing problems at its U.S. plants over the last few years, Reuters has reported.

The Branchburg facility has been the subject of a U.S. Department of Justice probe following a separate Reuters story in 2021 that detailed allegations of poor manufacturing practices and data falsification.

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