Feds launch investigation of Lilly factory in New Jersey

Federal officials have launched an investigation into an Eli Lilly and Co. factory in New Jersey following reports that records at the plant had been falsified or destroyed.

Indianapolis-based Lilly on Thursday said in a government filing that it has received a subpoena from the U.S. Justice Department for documents related to the factory and is cooperating with the investigation.

The factory makes complex biological drugs, including one of the company’s top-sellers, the diabetes drug Trulicity. The plant also makes bamlanivimab, an antibody used to treat COVID-19. Making biological drugs is an intricate, highly controlled process, requiring a large amount of documentation.

The investigation follows a Reuters report in March that a Lilly human resources officer alleged she had been forced out of her job at the factory after undertaking internal investigations of employee complaints about manufacturing lapses, falsified or destroyed records and staff shortages.

The U.S. Food and Drug Administration had been investigating complaints on record keeping and quality control at the factory, the story said.

The company said it has hired outside counsel to “conduct an independent investigation of certain allegations” related to the factory.

In response to questions Thursday from IBJ, Lilly did not say whether the outside investigation had discovered any irregularities at the plant, or whether the company has made any significant changes in management or operations there in recent months.

“Lilly is deeply committed to manufacturing high-quality medicines for patients who need them, and the safety and quality of our products is our highest priority,” the company said in a brief statement.

The Justice Department did not immediately respond to questions from IBJ.

The Reuters story said that according to 2018 emails among executives, company-mandated quality assurance documents were missing for Trulicity, and that a plant official who had raised concerns was terminated, the investigation said.

The story also raised allegations that substandard chemicals and ingredients were simply discarded and not reported as required; safety hazards existed, including the risk of electrocution from live wires; and quality assurance records disappeared or were doctored.

In one case, according to a 2018 email among managers, workers sifted through the garbage to find missing manufacturing records.

In some cases, workers reported they didn’t have supervisors to check with on how to properly handle contamination or disposal of unusable materials, the story said.

Lilly shares were down more than 1% Thursday afternoon, to $198.85 each.