Eli Lilly LLY -0.89% & Co. on Thursday said it received a subpoena from the Justice Department seeking documents related to the drugmaker’s manufacturing plant in Branchburg, N.J.
The Indianapolis company said it is fully cooperating with the investigation of issues at the plant, which has been flagged for deficiencies after inspections by the U.S. Food and Drug Administration and is the subject of employee allegations of document tampering.
The FDA in November 2019 notified Eli Lilly that during an inspection of the plant, where the company makes the blockbuster diabetes drug Trulicity and its Covid-19 antibody drug bamlanivimab, it had found that appropriate controls weren’t exercised over computers or related production and laboratory systems.
In a report on a subsequent inspection last year, the FDA noted a “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.” The agency also noted that the plant’s laboratory controls “do not include the establishment of scientifically sound and appropriate lest procedures designed to assure that drug substances conform to appropriate standards of identity, strength, quality and purity.”
After each inspection, Eli Lilly told the FDA that it would take corrective actions at the plant.
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Reuters in March reported that a former human-resources officer at the plant alleged that her job had been eliminated as she was looking into employee complaints about manufacturing problems related to Trulicity and other drugs, including allegations that records had been falsified or destroyed in the wake of manufacturing mistakes.
Earlier this month, Reuters reported that a group of employees had filed an internal complaint that accused a top quality official at the plant of altering documents required by government regulators in an effort to play down quality-control problems. An Eli Lilly representative told Reuters that an investigation was under way, and that the company would take appropriate action based on its outcome.
In a filing with the U.S. Securities and Exchange Commission on Thursday, Eli Lilly said it is thoroughly investigating allegations relating to the Branchburg site, which was part of its $6.5 billion acquisition of ImClone Systems Inc. in 2008, and that the safety and quality of its products “is our highest priority.”
Eli Lilly also noted that it had previously hired external counsel to conduct an independent probe. A company representative said Eli Lilly had no further comment on the matter beyond the SEC filing.
Write to Colin Kellaher at [email protected]
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