Feds demand docs from Eli Lilly on FDA-flagged New Jersey plant

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Eli Lilly said May 27 it has received a subpoena from the U.S. Justice Department seeking documents related to its manufacturing plant in Branchburg, N.J., where it makes it COVID-19 antibody drug bamlanivimab as well as its blockbuster diabetes drug Trulicity, according to The Wall Street Journal. 

The plant has been flagged for quality issues after two separate inspections by the FDA, as well as allegations from plant employees that a top quality official altered documents to play down quality issues. 

Eli Lilly said it is fully cooperating with the investigation of the plant. 

The FDA inspected the plant in November 2019 and stated that appropriate controls weren't exercised over computers or other related production and laboratory systems.

At a second inspection in 2020, the FDA said there had been 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."

The agency also said that the plant's laboratory controls didn't include appropriate procedures to make sure its drug products meet appropriate standards of "identity, strength, quality and purity," according to the Journal.

After both inspections, Eli Lilly told the FDA it would take corrective actions. 

A former human resources officer at the New Jersey plant alleged in March that her job was eliminated while she was looking into employee complaints about manufacturing problems related to Trulicity and other drugs, including allegations that records were falsified or destroyed following manufacturing mistakes, the Journal reported. 

A group of employees at the plant filed an internal complaint this month accusing a top quality official at the plant of altering documents required by government regulators in order to play down quality control issues. An Eli Lilly representative told Reuters that an investigation into the matter was underway and that the drugmaker would take appropriate action based on the outcome, according to the Journal

In its May 27 filing with the U.S. Securities and Exchange Commission, Eli Lilly said it is thoroughly investigating allegations related to the Branchburg plant and that the safety and quality of its products "is our highest priority." 

The company also said it had previously hired an external counsel to conduct an independent probe. An Eli Lilly spokesperson told the Journal the company has no further comment on the matter. 

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