(Reuters) - Eli Lilly and Co LLY.N said late on Tuesday it had hired an independent consultant to review a plant producing its COVID-19 antibody drug after receiving a notice from the U.S. health regulator.
The company reiterated that it had not received a warning letter from the U.S. Food and Drugs Administration (FDA) following its plant inspection, which was first reported by Reuters last week.
It received an Official Action Indicated (OAI) notice from the FDA in relation to issues at its Branchburg plant in New Jersey, Lilly reiterated. (bit.ly/3m9z1AE)
Reuters on Oct. 13 reported that inspectors who visited Lilly’s plant in Branchburg, New Jersey last November found data on various manufacturing processes had been deleted and not appropriately audited, according to government inspection documents.
Following its November inspection, the FDA classified the problems as the most serious level of violation, resulting in an OAI notice.
The problems could complicate the drugmaker’s bid for an emergency use authorization from the federal agency for its COVID-19 drug.
Last week, Lilly said other trials of its experimental coronavirus antibody therapy remain on track after a government-run study testing the treatment in hospitalized COVID-19 patients was paused due to safety concerns.
Reporting by Ann Maria Shibu in Bengaluru; editing by Patrick Graham, Josephine Mason and Shinjini Ganguli
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