In a memo dated Oct. 2, FDA compliance officers said that findings from a four-week inspection of the plant, which is located in Branchburg, N.J., “support a major failure of quality assurance.”
The officers said they feel it is “imperative that FDA take action,” Bloomberg reported.
The FDA inspection officers recommended that Eli Lilly receive a warning letter regarding the plant’s quality control issues, which is one of the FDA’s strongest enforcement measures.
In one incident described by the inspectors, an Eli Lilly employee allegedly used the wrong material in a critical purification step. In another, routine checks revealed a potential impurity in a drug, but the employee retested it to get a passing result instead of attempting to figure out why there were signs of an impurity, Bloomberg reported.
The inspectors also said Eli Lilly employees at the plant routinely overrode testing systems. The incidents “leave room for significant potential impact on product quality,” they wrote.
A warning letter from the FDA could slow Eli Lilly’s plan to have 1 million doses of the COVID-19 antibody drug ready by the end of the year. The New Jersey branch is one of five sites worldwide where Eli Lilly is making the drug, which it has named bamlanivimab, according to Bloomberg.
Eli Lilly said it hasn’t received a warning letter or any other enforcement letters about the plant from the FDA.
“The issues raised during the Branchburg inspections have our full attention, and we have been working closely with the FDA on remediation efforts,” the company told Bloomberg.
Eli Lilly told Bloomberg it believes the issues raised by the inspectors won’t affect drug quality or patient safety and said it is working to address them.
Read the full article here.
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