Inspectors with the U.S. Food and Drug Administration uncovered serious quality control problems at an Eli Lilly pharmaceutical plant that is ramping up to manufacture a COVID-19 drug touted by President Trump as "a cure" for the disease.
That's according to government documents and three sources familiar with the matter.
Government documents seen by Reuters show that inspectors who visited an Eli Lilly plant in New Jersey last November found that data on the plant's various manufacturing processes had been deleted and not appropriately audited.
Following that inspection, the FDA classified the problems as the most serious level of violation, resulting in an "Official Action Indicated" notice.
A former associate chief counsel at the FDA said that notice means quote "the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed."
Eli Lilly said it was working "aggressively" to address all concerns raised during the inspection.
The drugmaker also said the data deletions cited by the FDA were not related to production of the COVID-19 drug.
Separately, Eli Lilly said earlier on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment has been put on hold over a potential safety concern.
The company did not release information on what that problem was.
Eli Lilly's drug is similar to the Regeneron Pharmaceuticals treatment President Donald Trump received after he contracted COVID-19.