Lilly accused of substandard quality control at Covid-19 drug factories

An Eli Lilly and Co pharmaceutical manufacturing plant is pictured in Branchburg, New Jersey, US in this March 5 2021 file photo. Picture: REUTERS/MIKE SEGAR

Separately, FDA inspectors in March identified numerous manufacturing lapses at a second Lilly facility in Indianapolis that bottles the Covid-19 therapy and other drugs. The problems included substandard sanitation and quality control procedures, according to a preliminary FDA inspection report released to Reuters under open records laws. The Indianapolis inspection findings have not been previously reported.

“Depending on the outcome of that investigation, we will take appropriate action,” said Lilly spokesperson Kathryn Beiser. “Lilly has long-standing policies and procedures designed to enable — and encourage — individuals to come forward with information about any potential issues or concerns without fear of retribution.”

The Branchburg factory executive named in the complaint, Lydia Wible, did not respond to requests for comment. The complaint did not specify what alterations the employees believed were made to the documents but said Wible “rewrites factual data provided by subject matter experts to formulate responses she feels are more beneficial”.

Nathan Cortez, a law professor who specialises in FDA regulation at Southern Methodist University in Texas, said the employee accusations regarding Branchburg and Indianapolis could amplify Lilly’s problems with regulators. The complaint said Wible had, prior to recently altering the records required by the FDA, provided “fabricated” information including “fictitious numbers” to a Branchburg human resources investigator looking into potential manufacturing lapses.

In November 2019, about eight months after Mula’s departure, FDA inspectors showed up at the Branchburg plant for a routine inspection and cited some of the same problems Mula said she had repeatedly flagged to her bosses. The preliminary FDA report found that quality control data on various manufacturing processes had been deleted and not appropriately audited.

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And BillGates is worried other countries are substandard in their facilities or capabilities to manufacture their own vaccines against Covid. 🤔 freethepatent

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