Regulatory FDA cites quality issues at Rentschler and Eli Lilly...

FDA cites quality issues at Rentschler and Eli Lilly facilities


The FDA has raised concerns publicly following inspections of Eli Lilly and Rentschler Biopharma production sites in the last quarter of 2022 and the first month of 2023. The FDA identified three manufacturing-related shortcomings at Lilly’s Indianapolis location and five faults at Rentschler’s Baden-Wurttemberg, Germany, facility in Form 483 filings.

At Lilly’s location, the FDA claimed that the company’s aseptic procedure for an unidentified drug’s filling process was deficient. The FDA stated that operators handled unprotected sterile components in a manner that may introduce contaminants onto sterile surfaces in specific places. Additionally, the FDA deemed the processing areas of two filling lines to be substandard, citing sanitization methods as failing to satisfy its criteria.

Inspectors visited Lilly’s Indianapolis facility from October 17 to 21, 2022, and discovered that the site’s measures for preventing microbiological contamination were deficient. Reports from 2020 and 2021 indicated several events of microorganisms and endospores. Various different types of bacterial viruses were found during product sampling. The FDA also noted that the site’s quality unit did not always follow protocols, and nine bags of rejected intermediates were not carried to the “reject cage” as required by the site’s standard operating procedures.

Furthermore, the FDA identified that there weren’t any RPM specifications of the pump in the filling process followed by no documentation during drug-substance distribution during a previous inspection last year. The FDA also discovered two redacted pieces of equipment with discoloration rings below the top of the assembly, with no root cause identified and no documented risk assessment or remedial steps taken to address the discoloration.

Parallel to the Indianapolis site inspection and filing, the FDA rejected Eli Lilly’s ulcerative colitis candidate mirikizumab in April due to manufacturing-related deficiencies. It is unclear whether the rejection is related to this particular factory inspection, and Lilly did not reply to a request for comment. In recent years, Lilly has raised many red flags with the FDA. Aside from the Form 483 posted this week in Indianapolis, the FDA recorded multiple quality control lapses at Lilly’s plant in Branchburg, New Jersey, last year.

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