Recent inspections by the FDA at Eli Lilly's Branchburg, New Jersey plant have revealed significant manufacturing problems, reported Reuters.
The FDA identified eight deficiencies, including challenges in tracking the manufacturing process, lapses in quality controls, calibration issues, and inadequate facility maintenance during a July inspection. The inspection report, obtained by Reuters through a Freedom of Information Act request, highlighted concerns about the protection of electronic records, insufficient staff training for drug testing, and neglect of equipment, raising potential risks of data manipulation and contamination.
In a statement to Reuters, Eli Lilly said it responded to the inspection by seeking FDA approval for "additional flexibility" to produce the migraine treatment Emgality on a different line. While the company said that most issues were addressed during the inspection, experts, including former FDA official Steven Lynn, expressed serious concerns about the recurring problems at the Branchburg facility.
The FDA declined to comment on the specific issues, but the manufacturing lapses could be categorized as "Official Action Indicated." The severity of the FDA's response will depend on the company's corrective actions to ensure drug quality.
In 2021, the U.S. Department of Justice delved into quality concerns surrounding the same Eli Lilly plant in New Jersey, responsible for manufacturing the COVID-19 treatment, bamlanivimab.
Reuters had reported employee allegations that an executive at the facility had destroyed FDA-required documents to conceal severe quality lapses. This incident marked a recurring problem, as a former human resources officer accused the company earlier in the year of destroying or falsifying documents related to quality issues.
A previous FDA inspection in 2019 at the plant uncovered various quality problems, including inadequate investigations into issues tied to the production of the company’s Trulicity drug, resulting in an Official Action Indicated. Responding to these challenges, the company enlisted an independent consultant to address compliance issues at the facility.
