US FDA finds new manufacturing lapses at Eli Lilly plant
Lilly said in a statement that tirzepatide, the active ingredient in Mounjaro and Zepbound, was not manufactured at the Branchburg plant
Washington: US 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 a news agency.
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.
The inspection report, which a news agency obtained through a Freedom of Information Act request, was partially redacted to remove the names of any products affected.
Lilly said in a statement to a news agency that the company had asked the FDA to allow for "additional flexibility" to manufacture migraine treatment Emgality on a different production line if needed in the future.
The drugmaker said that no other products made at the facility were impacted by the inspection.
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 capitalisation. Its shares rose 59 per cent 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, a news agency has reported.
The Branchburg facility has been the subject of a U.S. Department of Justice probe following a separate a news agency story in 2021 that detailed allegations of poor manufacturing practices and data falsification.
Lilly and the Justice Department declined to comment on the status of that inquiry.
