FDA re­veals QC is­sues at Eli Lil­ly’s man­u­fac­tur­ing site in New Jer­sey — re­port

One of Eli Lil­ly’s man­u­fac­tur­ing sites has been in the crosshairs of the FDA and the De­part­ment of Jus­tice for some time now, and an in­spec­tion re­port from this sum­mer is not paint­ing a pos­i­tive pic­ture.

Ac­cord­ing to a re­port from Reuters, an in­spec­tion in Ju­ly by the FDA re­vealed sev­er­al is­sues sur­round­ing qual­i­ty con­trol at a Lil­ly man­u­fac­tur­ing site in Branch­burg, NJ. The Form 483 in­spec­tion re­port stat­ed that em­ploy­ees at the fa­cil­i­ty did not track drug batch­es that were po­ten­tial­ly taint­ed and were sup­posed to be tracked by the fa­cil­i­ty’s QC unit. The re­port al­so found de­bris in a pro­duc­tion area and raw in­gre­di­ents not be­ing prop­er­ly con­trolled.

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