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# Whistleblower Sues Lilly Over GMP-related Termination
- URL: https://www.fdaweb.com/whistleblower-sues-lilly-over-gmp-related-termination/
- Published: 2022-06-07T12:00:00.000Z
- Updated: 2026-09-14T17:47:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151997

A former employee at Eli Lilly has filed a wrongful termination suit against the pharmaceutical manufacturer, claiming she was fired in retaliation for allegedly raising issues about GMP problems and data falsification involving top-selling Type 2 diabetes drug Trulicity. The plaintiff, **Amrit Mula**, was terminated in 2019 after bringing GMP issues to management’s attention, according to a [Reuters report](https://www.reuters.com/business/healthcare-pharmaceuticals/whistleblower-sues-eli-lilly-over-drug-manufacturing-problems-2022-06-07/?ref=fdaweb.com). The U.S. Department of Justice last year reportedly launched a criminal probe into alleged manufacturing troubles at an Eli Lilly plant in Branchburg, NJ ([see earlier story](https://www.fdaweb.com/justice-department-hits-eli-lilly-with-subpoena/)). 

A Lilly statement called Mula’s allegations “baseless” and said it looks forward to the opportunity to defend itself in court. The company also said it continues to cooperate with a Justice Department subpoena and to work collaboratively with FDA, according to Reuters, 

Mula had worked at the New Jersey facility since 2004, and starting in 2018 she began raising issues internally about GMP violations. “Lilly executives responded by marginalizing, harassing and eventually terminating her position under false pretenses,” the lawsuit contended. 

In 2021, a Lilly investigation into whether a company executive altered manufacturing documents required by FDA found no wrongdoing, according to an earlier [Reuters report](https://www.reuters.com/world/us/exclusive-eli-lilly-memo-says-firm-did-not-make-false-statements-fda-2021-06-10/?ref=fdaweb.com). Law firm Covington & Burling spearheaded the probe of an internal Lilly complaint that alleged a Branchburg, New Jersey factory executive changed technical documents required by regulators to downplay serious quality control problems at the facility that also makes the company’s bamlanivimab Covid-19 therapy ([see earlier story](https://www.fdaweb.com/lilly-employees-say-exec-rewrote-fda-reports/)). 

The manufacturing facility has been under FDA scrutiny for several years. In 2020, FDA posted a [Form FDA-483](https://www.fda.gov/media/143340/download?ref=fdaweb.com) detailing significant quality and laboratory control issues found during an 8/2020 reinspection at the Branchburg facility. The FDA-483 said that there was a quality failure to “thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.” For example, FDA said incidents that occurred during GMP activities that may have had an impact on product quality were not investigated.   

The reinspection followed an 11/2019 inspection and [according to an FDA-483](https://www.fda.gov/media/143341/download?ref=fdaweb.com) appropriate controls were not being exercised over computers or related production systems at the facility. The agency said that electronic files identified as Calibration Study, Qualification Study and Verification Study had been deleted, adding that the “deleted incidents and related audit trail were not reviewed by the quality unit.” Appropriate controls were also not exercised over computers or related laboratory systems, FDA said, specifically identifying quality control laboratory data stored on multiple stand-alone equipment computer systems that were not secured from modification or deletion.