⁍ Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited.

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⁍ The FDA classified the problems as the most serious level of violation, resulting in an ‘Official Action Indicated’ (OAI) notice.

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⁍ Separately, Lilly said on Tuesday it had paused its clinical trial for the COVID drug in hospitalized patients ‘out of an abundance of caution’ over a potential safety concern.

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– President Trump has been boasting about the ” cures” COVID-19 has brought him since he contracted the H1N1 virus. But government documents and three sources tell Reuters that FDA inspectors uncovered serious quality control problems at an Eli Lilly and Co plant that is ramping up to manufacture one of two promising COVID-19 drugs. The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals that was given to the president during his bout with COVID-19. Trump, who credits the Regeneron drug with speeding his recovery, has called for both therapies to become available immediately on an emergency basis, raising expectations among some scientists and policy experts that the administration will imminently release an Emergency Use Authorization for the drug. But the findings by the US Food and Drug Administration inspectors at the Lilly manufacturing facility, which have not been disclosed previously, could complicate the drugmaker’s bid for a so-called emergency use authorization from the federal agency, two of the sources and two outside legal experts tell Reuters. That’s because US law generally requires compliance with manufacturing standards for authorization of a drug. Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited. “The deleted incidents and related audit trail were not reviewed by the quality unit,” the FDA inspectors wrote. The FDA classified the violations as the most serious level of violation, which “means that the violations are serious enough and have a significant impact on the public health that something needs to be fixed,” a former FDA lawyer tells Reuters. Lilly confirmed that the violations were not related to production of the drug used for the drug used to test to determine if the drug’s whether the drug will be able to befit the drug will be tested, which be tested.