The Food and Drug Administration investigators last November found major quality control issues at an Eli Lilly and Co. (NYSE: LLY) facility that is preparing to produce the company’s COVID-19 antibody treatment, according to a report from Reuters.
The report cites government inspection documents, which say investigators who visited the New Jersey facility found that manufacturing process data for the plant had been deleted and “not appropriately audited.”
Reuters says the heavily-redacted documents did not show more specific findings, only that, “The deleted incidents and related audit trail were not reviewed by the quality unit.” The findings resulted in the FDA issuing an “Official Action Indicated” for the plant.
The pharmaceutical company told Reuters it has launched a “comprehensive remediation plan” and is working “aggressively” to address the issues raised by inspectors, including increasing staffing at the plant.
Lilly said the data deletion issue is not related to the production of the antibody treatment.
“These findings do not impact product quality or patient safety, as outlined in a detailed assessment submitted to FDA,” the company said in a statement to Reuters. “Lilly continues to provide updates to the FDA on progress towards completion of our detailed plan.”
You can read the full story from Reuters by clicking here.
The report comes one day after Lilly announced a pause in its clinical trial of the treatment led by the National Institutes of Health.