Lilly Plant Making Covid Drug Flagged Again by Inspectors
- FDA inspection papers show quality-control issues at key plant
- Drugmaker says it is working with FDA on remediation efforts
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U.S. drug-safety inspectors have found continuing quality-control problems at a New Jersey plant Eli Lilly & Co. is using to help produce its Covid-19 antibody therapy, posing a potential obstacle to the company meeting its goal of producing 1 million doses by year-end.
In an Oct. 2 memo, Food and Drug Administration compliance officers wrote that findings from an inspection of the facility in July and August “support a major failure of quality assurance.” They noted that Lilly planned to make its antibody therapy at the plant and said the inspection group “feels it is still imperative that FDA take action.”