FDA cites qual­i­ty is­sues at Rentschler and Eli Lil­ly fa­cil­i­ties

A year af­ter the FDA in­spect­ed a Rentschler Bio­phar­ma man­u­fac­tur­ing site in Ger­many, the agency dis­cov­ered more is­sues.

In an in­spec­tion that took place in late Feb­ru­ary and ear­ly March, the FDA made five ma­jor ob­ser­va­tions at Rentschler Bio­phar­ma’s fa­cil­i­ty in Laupheim, Ger­many. The reg­u­la­tor de­scribes “ob­ser­va­tions” as con­di­tions or prac­tices that may vi­o­late FDA re­quire­ments.

In­spec­tors found the site’s pro­ce­dures to pre­vent mi­cro­bial con­t­a­m­i­na­tion were not up to par. The re­port not­ed nu­mer­ous in­stances of mi­croor­gan­isms, en­dospores and oth­er mi­cro­bial con­t­a­m­i­nants in man­u­fac­tur­ing suites be­tween 2020 and 2021, with sev­er­al types of bac­te­ria found dur­ing en­vi­ron­men­tal mon­i­tor­ing in prod­uct sam­ples.

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