After FDA inspectors visited Eli Lilly and Rentschler Biopharma production sites in October 2022 and early 2023, respectively, the U.S.' drug regulator is making concerns about the facilities public.
In Form 483 filings posted this week, the FDA flagged Lilly's site in Indianapolis for three manufacturing-related shortfalls and Rentschler's Baden-Wurttemberg, Germany, site for five deficiencies.
At Lilly's site, the regulator said the company's aseptic technique for an undisclosed drug's filling operation was "deficient." Specifically, operators "handled unprotected sterile components" in a way that "may introduce contaminants onto sterile surfaces" in certain areas, the FDA said.
Aside from that observation, the FDA flagged "processing areas" for two filling lines as substandard. Again, the FDA flagged sanitization procedures as not meeting its standards.
Inspectors visited Lilly's Indianapolis site from Oct. 17-21, 2022.
In parallel to the Indianapolis site inspection and filing, the FDA in April rejected Eli Lilly's ulcerative colitis prospect mirikizumab over manufacturing-related shortfalls.
It isn't immediately clear whether the rejection is tied to this specific plant inspection, and Lilly did not respond to a request for comment.
Lilly has raised manufacturing flags at the FDA multiple times in recent years. Aside from the Indianapolis Form 483 posted this week, the FDA last year recorded multiple quality control lapses at Lilly’s plant in Branchburg, New Jersey.
Problems at the site date back to at least 2020, when the FDA closely scrutinized the company's production of COVID-19 antibodies.
As for Rentschler Biopharma, the FDA's site visits in February and March uncovered issues including inadequate procedures to prevent microbial contamination, quality monitoring shortfalls and improper disposing of rejected biological substances.
After receiving the Form 483, Rentschler "immediately reviewed these observations and responded with a plan of comprehensive corrective and preventive actions to address the identified topics," a spokesperson said over email.
"These were communicated to the FDA in an official response letter," the Rentschler spokesperson added. "Since then, our team has addressed all the processes and quality standards in accordance with the FDA’s requirements from the audit. During the whole process, we have been in close contact with our clients and the FDA."
Rentschler is also no stranger to the FDA's production scrutiny. Last June, the FDA published a Form 483 flagging nine observations at a separate plant in Germany. Those findings stemmed from a site visit in February 2022.
Editor's note: This story was updated with a statement from Rentschler Biopharma.