FDA Highlights Quality Check Issues At Eli Lilly's New Jersey Manufacturing Site

An inspection in July by the FDA revealed several issues surrounding quality control at Eli Lilly And Co's LLY manufacturing site in Branchburg, NJ.
According to Reuters, the Form 483 inspection report stated that employees at the facility did not track contaminated drug batches and were supposed to be tracked by the facility's quality check unit.
The report also found unknown debris in a production area and raw ingredients not being adequately controlled.
The report did not say whether the tainted medicines were ultimately shipped to customers or discarded. The drug batches included widely used diabetes medicine Trulicity, migraine therapy Emgality, and cancer treatments Erbitux and Cyramza.
This is not the first time the Branchburg facility has found itself in hot water. Reuters stated that in November 2019, quality control data were found to have been deleted and not adequately audited. In March 2020, the FDA classified the findings as "Official Action Indicated."
Last year, Eli Lilly employees 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.
According to the employee complaint, the Branchburg plant has not shipped new batches of the COVID-19 drug bamlanivimab in nearly two months.
Price Action: LLY shares are up 1.36% at $328.29 on the last check Tuesday.
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