November 23, 2022

FDA highlights quality control issues at Eli Lilly’s New Jersey manufacturing site – Eli Lilly (NYSE:LLY)

  • A July inspection by the FDA revealed several quality control issues at Eli Lilly and Co THERE IS manufacturing site in Branchburg, NJ.
  • According to Reuters, the Form 483 inspection report said the facility’s employees were not tracking contaminated drug lots and were supposed to be tracked by the facility’s quality control unit.
  • The report also revealed unknown debris in a production area and raw materials not adequately controlled.
  • The report did not say whether the contaminated drugs were ultimately shipped to customers or discarded. The drug bundles included widely used diabetes drug Trulicity, migraine treatment Emgality, and cancer treatments Erbitux and Cyramza.
  • This isn’t the first time the Branchburg facility has found itself in hot water. Reuters said that in November 2019 quality control data was removed and not properly audited. In March 2020, the FDA classified the findings as “Official Indicated Action.”
  • Last year, Eli Lily employees accused a factory executive of altering documents required by the FDA to downplay quality control issues at the Branchburg, New Jersey factory producing its COVID-19 treatment.
  • According to the employee complaint, the Branchburg plant has not shipped new batches of the COVID-19 drug bamlanivimab for nearly two months.
  • Price action: LLY shares are up 1.36% at $328.29 when last checked on Tuesday.
  • Photo via Wikimedia Commons