An anonymous staff member or group filed a report on April 8 with the company, alleging a top quality official at its Branchburg, N.J. factory rewrote its technical experts’ findings to make them more favourable to the firm. The U.S. Food and Drug Administration has been investigating the plant. (Reuters)
Talking point: A source told Reuters the allegedly altered findings involved drug production, including of bamlanivimab, an antibody therapy for COVID-19 developed with Vancouver-based AbCellera. In March, the FDA identified some manufacturing issues at a second facility in Indianapolis. An Eli Lilly spokesperson confirmed to The Logic that it received an anonymous complaint, and that a third-party investigation is ongoing. “We will take appropriate action” after receiving the results of the investigation, they said. The spokesperson also confirmed the FDA Indianapolis inspection and said that “none of the issues raised … affected any finished product or product in the marketplace that was manufactured in this facility.” AbCellera did not immediately respond to a request for comment.