Eli Lilly refutes FDA quality concerns at New Jersey facility producing COVID-19 drug

pharmafile | October 21, 2020 | News story | Manufacturing and Production, Research and Development COVID-19, Eli Lilly, FDA, pharma 

Eli Lilly has rebutted reports of FDA quality assurance concerns at its manufacturing facility in Branchburg, New Jersey, where it is producing bamlanivimab, an experimental antibody therapy to treat COVID-19, a week after the company stopped recruiting for clinical trials of the drug.

Following a four-week inspection ending on 21 August, compliance officers on behalf of the FDA wrote in official documentation on 2 October that “a major failure of quality assurance” had been identified at the site, adding that it was “imperative that FDA take action”. The ultimate recommendation of the investigation was that Lilly be issued with a warning letter over the concerns.

According to documentation related to the inspection, employees at the facility ignored potential product quality issues and testing systems in the production process. The documents highlighted at least one instance where a staff member at the facility was observed using the wrong material at an essential stage in the product purification process, while, in another example, an employee retesting a product flagged as potentially impure in order to have it pass inspection, rather than following up on the source of the possible impurity.

The officers did not test any of the products produced at the facility, however, but they noted that the other issues they identified would suggest a “significant potential impact on product quality”.

Lilly responded to the latest allegations on its website on 20 October: “The issues raised during the Branchburg inspections have our full attention and we have been working closely with FDA on remediation efforts. Lilly has engaged an external consultant to conduct a comprehensive independent review of systems at the Branchburg site, and we have increased staffing and resources at Branchburg to manage the additional activity levels we are experiencing related to production of active pharmaceutical (API) ingredients.

“We are confident that the issues raised during the Branchburg inspections did not impact product quality or patient safety. While Lilly has not received a warning letter or other enforcement letter from the FDA related to this matter, we nevertheless take all FDA inspection findings very seriously and are urgently working to address their concerns.”

Matt Fellows

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