Exclusive-US Discovers New Quality Issues at Lilly Drug Factory

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By Dan Levine and Marisa Taylor

(Reuters) – U.S. drug inspectors recently registered several new quality control issues at an Eli Lilly and Co plant that is already under federal investigation over manufacturing failures, according to a government report reviewed by Reuters.

The U.S. Food and Drug Administration’s findings come nearly three years after agency inspectors began documenting quality control issues at the same Lilly plant in Branchburg, New Jersey. Last year, the US Department of Justice launched a criminal investigation following a Reuters article that detailed allegations of poor manufacturing practices and tampering with data at the factory.

FDA inspectors returned to the plant last July, spending 12 days there. They found that Lilly staff did not adequately track batches of potentially contaminated drugs that were supposed to be inspected by the company’s quality control unit, according to a redacted copy of the report, known as of “Form 483,” obtained by Reuters under a Freedom of Information Act request.

Inspectors wrote that Lilly staff had found “unknown debris” in a production area and that the raw ingredients of drugs produced there “were not sufficiently controlled pending satisfactory completion of evaluation by the quality unit. According to the FDA’s website, its inspectors issue 483 forms when they have observed conditions that may violate federal regulations.

Lilly did not respond directly to questions about the FDA inspectors’ findings. The company said it has “rigorous quality systems in place to ensure compliance with stringent regulatory requirements.”

The Justice Department declined to comment, and the FDA did not immediately respond.

The FDA report did not say whether the drugs in question were ultimately shipped to customers or discarded. The drug bundles included diabetes drug Trulicity, migraine treatment Emgality, as well as cancer treatments Erbitux and Cyramza, according to the report.

“The FDA is telling the company that they’re doing things up front before quality control is approved. That’s a big no-no,” said Steven Lynn, former chief of the Office of Manufacturing and FDA product quality. Lilly also removed references to several drug lots, including Trulicity, from its own internal report on potential contamination, the FDA found.

If problems at a plant aren’t fixed, the FDA could escalate the problem by issuing a warning letter, and ultimately could order a company to stop producing certain drugs at a facility. The FDA did not disclose any sanctions against Lilly regarding the plant and did not respond to a question about potential enforcement actions.

Susan Bain, an assistant professor of regulatory and quality science at the University of Southern California and a former FDA inspector, said the findings raise questions about whether Lilly is “shipping product before quality ( control) does not complete its investigation”. Given the factory’s history, Bain said, “I would say they don’t take quality seriously.”

“It’s a problem because if something happens along the way and quality control doesn’t pick it up, then the product can go to market,” said Lynn, the former FDA official. “That’s how mistakes happen.”

The FDA requires pharmaceutical companies to closely follow quality control documents, including recording any deviations from required procedures. Record keeping requirements are essential to ensure drug quality, as defects may not be obvious to consumers or physicians.

In November 2019, FDA inspectors discovered that quality control data had been suppressed and not properly audited at the New Jersey plant. In March 2020, the FDA classified the findings as “Official Action Indicated” or OAI, which is its most serious violation category.

Reuters, in its article last year on alleged poor manufacturing practices, reported that a human resources manager at Lilly alleged that she was forced out of her job at the factory after undertaking investigations. on employee complaints about manufacturing failures, falsified or destroyed records, and staff shortages. .

The human resources manager then filed a whistleblower complaint, which is still pending. Lilly denied the allegations.

(Reporting by Dan Levine in San Francisco and Marisa Taylor in Washington; Editing by Michele Gershberg and Matthew Lewis)

Copyright 2022 Thomson Reuters.

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