Specifically, the agency cited issues with the drugmaker’s aseptic technique in the filling line. It also noted that setup practices observed were “partially over unprotected sterile surfaces of components,” which could lead to contamination.
The Eli Lilly facility at the center of the shortcomings is located in Indianapolis.
“For nearly 150 years, Lilly has remained deeply committed to manufacturing high-quality medicines for patients who need them — nothing is more important to us,” an Eli Lilly spokesperson told Becker’s. “We are working closely with the FDA to address and resolve their observations. 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.”
