The FDA inspectors discovered that Lilly’s employees had not properly tracked contaminated drugs batches that were supposed to be checked by the company's quality-control division
Eli Lilly Corporate Center. (Credit: Momoneymoproblemz from Wikimedia Commons)
The US Food and Drug Administration’s (FDA) drug inspectors have reportedly uncovered multiple quality-control issues at Eli Lilly (Lilly) plant in Branchburg, New Jersey.
The drug facility in question is already the focus of a federal probe over lapses in manufacturing, reported Reuters, citing a government report.
The FDA discovered that Lilly’s employees had not properly tracked contaminated drug batches that were intended to be checked by the company’s quality-control division.
In a production area, Lilly’s staff discovered “unknown debris,” according to the inspectors. Furthermore, raw drug components manufactured in the area were not controlled adequately pending satisfactory completion of assessment by the quality-control unit, as per the publication.
In response to the FDA inspectors’ findings, Lilly has been quoted by the publication, stating that it has “rigorous quality systems in place to ensure compliance with stringent regulatory requirements.”
According to the FDA report, the drug batches include diabetes drug Trulicity, migraine therapy Emgality, and cancer drugs Cyramza and Erbitux.
The health regulator also found references to several batches of drugs, including Trulicity, from Lilly’s own internal report about the potential contamination were omitted.
If the issues are not fixed, the FDA can issue a warning letter and eventually, it could order to cease production of some drugs at a facility, reported the news agency.
FDA Office of Manufacturing and Product Quality former head Steven Lynn, has been quoted by Reuters, as saying: “The FDA is telling the company they’re doing stuff ahead of time before quality control signs off on it. That’s a big no-no.”