The Food and Drug Administration flagged quality issues it found with Eli Lilly’s Indianapolis production site in an inspection report published May 1st.
The agency highlighted three observations upon inspecting the pharmaceutical company’s facility in October. This includes issues with Lilly’s aseptic techniques, which prevent contamination, in its drug filling operations.
The FDA labeled the techniques as “deficient,” noting that production operators “handled unprotected sterile components” in a way that “may introduce contaminants onto sterile surfaces.” Operators additionally did not always use the unsoiled part of cleaning wipes on other items.
Inspectors also observed that Lilly’s processing areas for two filling lines did not meet standards for activities related to the system it uses to reduce interventions between drugs and their environment.
“We are working closely with the FDA to address and resolve their observations,” Lilly told Manufacturing Dive in an emailed statement. “Importantly, as we are executing these actions, we can confirm that the observations noted by the FDA have not impacted the quality of any product in the marketplace.”
This is not the first time Lilly has been under scrutiny by the FDA. Reuters reported in October that the FDA recorded multiple new quality control issues at Lilly’s factory in Branchburg, New Jersey, which is already under criminal investigation by the Department of Justice for poor manufacturing practices and data falsification.