U.S. FDA inspectors recently found several new quality control problems at the same New Jersey Eli Lilly and Co. plant that is already the subject of a federal investigation says Reuters, citing a government report reviewed by the news outlet.
According to Reuters — who viewed a redacted 483 form — FDA inspectors visited Lilly's Branchburg, New Jersey plant this past July, launching a 12-day inspection. Inspectors found that plant personnel did not adequately track potentially contaminated drug batches that were supposed to be inspected by the drugmaker's quality control unit. "Unknown debris" was found in a production area, and raw drug ingredients "were not adequately controlled pending satisfactory completion of evaluation by the quality unit."
According to the report, the affected batches included were diabetes med Trulicity, migraine therapy Emgality and two cancer treatments, Erbitux and Cyramza.
The same plant has been the subject of quality reports for several years. An FDA inspection back in 2019 revealed several quality problems, including a failure to properly investigate issues related to the production of the company’s blockbuster Trulicity, resulting in an Official Action Indicated from the agency. Then, in 2021, Reuters reported that a former human resources officer tasked with investigating manufacturing issues has accused the company of destroying or falsifying documents related to quality issues. Later that year, Lilly reported that the DOJ has subpoenaed the company for documents connected to the same plant, this time in relation to Lilly's COVID-19 treatment, bamlanivimab.
The recent 483 report reviewed by Reuters did not specify if any of the drugs flagged in the inspection reached the market. Lilly did not comment directly on the FDA inspection, instead assuring Reuters that it has "rigorous quality systems in place to ensure compliance with stringent regulatory requirements."
