FDA tightens scrutiny of COVID-19 drug made at Eli Lilly plant in New Jersey

The FDA is requiring Eli Lilly to hire a third-party consultant to review quality data for batches of its COVID-19 antibody drug made at a New Jersey plant before the drug can be sent to distributors after two separate inspections found quality control issues at the plant. 

The requirement was written in the FDA's emergency use authorization of the drug, bamlanivimab, which the FDA granted Nov. 9. If the third-party consultant finds any discrepancies in the data that may suggest the quality of the drug has been compromised, it can't be released until those issues are addressed. 

The agency said Eli Lilly must hire a consultant to verify quality testing data at the plant in Branchburg, N.J. In two separate inspections conducted at the plant in the last year, the FDA said it found quality control issues that "support a major failure of quality assurance." 

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. 

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. 

Eli Lilly said Nov. 3 that it has been working to address four issues observed by the FDA in the inspections and have performed in-depth investigations of each area of concern.

An Eli Lilly spokesperson told Becker's that the issues the FDA reported from its inspections did not affect the quality of any active pharmaceutical ingredient made at the Branchburg plant. The spokesperson also said that the requirements for a third-party consultant in the emergency authorization haven't affected the drug's production and that, within hours of the FDA's authorization, Eli Lilly shipped 88,000 doses of bamlanivimab to its distributor, AmerisourceBergen. 

"We have a high degree of confidence in the quality of the active pharmaceutical ingredient that we make in Branchburg and we want to ensure full confidence from the FDA and the public in the medicines we manufacture. As we urgently bring this treatment for COVID-19 to patients, we are unwavering in our commitment to the safety and quality of our medicines," Eli Lilly said.


Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.


Featured Whitepapers

Featured Webinars