NJ plant woes continue for Lilly with reports of FDA 483

Eli Lilly has received an FDA Form 483 citing further manufacturing issues at its Branchburg, New Jersey facility, Reuters reports.

The Reuters’ exclusive was based on a redacted copy of the Form 483 – obtained under a Freedom of Information Act request – which followed an inspection at the Branchburg facility by the US Food and Drug Administration (FDA) in July.

Among the issues highlighted, Reuters said: “Lilly personnel found ‘unknown debris’ in a production area and that raw drug ingredients produced there ‘were not adequately controlled pending satisfactory completion of evaluation by the quality unit.’”

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The 25,000 square-foot facility makes several Lilly biologics, including cancer drugs Erbitux (cetuximab) and Cyramza (ramucirumab), type 2 diabetes treatment Trulicity (dulaglutide), and COVID-19 monoclonal antibody bamlanivimab.

The 483 is the latest problem for the Branchburg site, which has been subject to quality-control issues for the past few years. Following an inspection in 2019, the site received an “Official Action Indicated” (OAI) notice with the FDA noting processing data had been deleted and not appropriately reviewed by the firm’s quality unit.

This led to a statement from Lilly in October 2020 stating the firm had taken remediation efforts, including engaging an external consultant to conduct a comprehensive independent review of systems, and increasing staffing and resources at the site.

However, the US Department of Justice launched a criminal investigation at the facility last year, following another Reuters story that detailed allegations of poor manufacturing practices and data falsification.

While repercussions for Lilly could be serious, Evercore ISI analyst Umer Raffat remained relaxed, especially in regard to potential supply disruptions.

“The filings I reviewed suggest binders of validation protocols had been missing,” he wrote in a note. “Also, old reports of Lilly employees improperly disposing large amount of buffer solution (without proper neutralization) intended for Trulicity.  FDA had investigated this and determined it to be a deviation and NOT an observation.”

He continued: “Around 2019, batch release investigations revealed out of spec batches weren’t being reported and unvalidated calculations may have been used to ‘pass.’ But again, all of this is well known for multiple years now … and in my experience tracking FDA inspections, you’ll see instances like this (and much worse) in manufacturing sites across biopharma companies.”