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Eli Lilly Under FDA Scrutiny At Its COVID-19 Drug Manufacturing Facilities Amid Staff Accusations: Reuters

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Eli Lilly Under FDA Scrutiny At Its COVID-19 Drug Manufacturing Facilities Amid Staff Accusations: Reuters
  • Eli Lilly & Co (NYSE: LLYemployees have reportedly accused a factory executive of altering documents required by the FDA to downplay quality control problems at Branchburg, New Jersey plant producing its COVID-19 treatment.
  • Reuters notes that an unsigned report was filed last month, which claims that the executive rewrote findings by Lilly’s technical experts to make the conclusions appear more favorable to the company.
  • The findings involved the production of drugs, including Lilly’s COVID-19 therapy, whose use in the United States is funded by the federal government.
  • Contacted by Reuters, Lilly confirmed it had received the recent employee complaint about the Branchburg plant. The company said it could not comment further, stating that an investigation was underway.
  • According to the employee complaint, the Branchburg plant has not shipped new batches of the COVID-19 drug bamlanivimab in nearly two months.
  • Separately, FDA inspectors in March identified several manufacturing negligences at a second Lilly facility in Indianapolis that bottles the COVID-19 therapy and other drugs.
  • According to a preliminary FDA inspection report released to Reuters, the problems included substandard sanitation and quality control procedures.
  • Lilly also confirmed that it had submitted a response to the FDA about its recent inspection of the Indianapolis plant.
  • “The FDA found serious concerns on multiple fronts,” said Steven Lynn, a former head of the FDA’s Office of Manufacturing and Product Quality, who reviewed the inspection report for Reuters. “Lilly has a lot of work to do.”
  • Price Action: LLY shares are up 2.59% at $193.07 in the market trading session on the last check Wednesday.
 

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