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Whistleblower sues Eli Lilly over drug manufacturing problems -Breaking

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© Reuters. FILEPHOTO: A Branchburg-based pharmaceutical manufacturing plant of Eli Lilly and Company can be seen at 50 ImClone Dr, Branchburg (New Jersey), March 5, 2021. Picture taken March 5, 2021. REUTERS/Mike Segar/File Photo/File Photo

Marisa and Dan Levine

(Reuters) – A former human resources officer at Eli Lilly & Co (NYSE:) sued the pharmaceutical company on Monday, alleging she was terminated after pointing out poor manufacturing practices and data falsification involving its blockbuster diabetes drug.

Amrit Mula is the plaintiff. She alleges that she violated an employee protection law. After a Reuters report that highlighted Mula’s claims, the U.S. Department of Justice launched a criminal investigation into alleged manufacturing errors at a Lilly facility in New Jersey.

Unable to immediately answer questions regarding the lawsuit and the current status of the Justice Department’s investigation, a Lilly spokesperson didn’t respond.

Last year, the company declared that Lilly is deeply committed in manufacturing quality medicines for the patients who are most affected by them.

Mula stated that she tried to settle the controversy without triggering litigation, and was unable to comment.

A request for comment was not received by the Justice Department immediately.

Mula, a New Jersey worker who started at the plant in 2004 claims in the suit that she pressured the site’s leaders to correct manufacturing violations in 2018. Mula also claimed in the lawsuit.

According to the suit, which was filed in New Jersey Federal Court, “Lilly executives replied by marginalizing and harassing her position, before finally terminating it under false pretenses.”

Branchburg was visited by FDA inspectors on November 19, 2019. The inspection revealed that Quality Control data had been removed and the plant wasn’t properly audited.

According to Federal records, FDA cited problems for 2020 under the “Official Action Indicated” category. OAI is their most severe form of violation. FDA did not take further action nor respond to requests for comment.

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