FDA hits both Lilly and Rentschler with 483s

Aseptic manufacturing concerns have landed Eli Lilly and Rentschler separate Form 483s at facilities that have previously fallen foul of the US FDA.

The US Food and Drug Administration (FDA) inspection of the 1555 South Harding Street, Indiana, Indianapolis facility in October 2022 resulted in Eli Lilly receiving a Form 483 with three observations.

The document cites Lilly’s aseptic technique for drug product filling operation as “deficient,” with concerns surrounding unprotected sterile surfaces and the actions of operators at the facility.

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The second heavily redacted observation found the process for personnel monitoring deficient, while the third said the firm’s method for disinfecting did not adequately support the sanitization procedure observed during production setup.

The drug referenced was redacted in the 483. However, the publication comes weeks after the FDA issued a complete response letter rejecting Lilly’s ulcerative colitis (UC) monoclonal antibody mirikizumab due to undisclosed manufacturing concerns.

The facility has previously been slammed for sterile production deficiencies, receiving a 483 with seven observations following an inspection in February and March 2021.


Meanwhile over in Germany, the FDA has hit contract development and manufacturing organization (CDMO) Rentschler with a 483 citing five observations at its Laupheim plant.

Among the issues, the Agency labeled procedures to prevent microbial contaminations as “inadequate” and said “responsibilities of the quality unit are not always fully followed.”

Like Lilly, this is not Rentschler’s first rodeo when it comes to 483s. An inspection at Laupheim in February 2022 ended with a Form 483 with nine observations. Four months later, the firm told this publication all of those observations had been closed out by the FDA with no further comment  following a rapid review and remediation.