The U.S. Food and Drug Administration findings come nearly three years after the agency's inspectors began documenting quality-control issues at the same Lilly plant in Branchburg, New Jersey. FDA inspectors returned to the plant this past July, spending 12 days there. Lilly did not directly respond to questions about the FDA inspectors' findings. The FDA report did not say whether the medicines in question were ultimately shipped to customers or discarded. In November 2019, FDA inspectors found that quality-control data had been deleted and not appropriately audited at the New Jersey plant.

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