Eli Lil­ly is­sues re­sponse to Form 483 at In­di­anapo­lis plant

Af­ter an Aug. 12 dat­ed Form 483 called out Eli Lil­ly’s In­di­anapo­lis ster­ile in­jecta­bles plant for sev­er­al laps­es in qual­i­ty, the com­pa­ny has is­sued a 95-page re­sponse.

Sev­en key ob­ser­va­tions came out of the in­spec­tion from the FDA, which took place be­tween Feb­ru­ary and March of this year. Among them was the lack­lus­ter en­vi­ron­men­tal mon­i­tor­ing con­trol in asep­tic pro­cess­ing ar­eas, as well as a fail­ure to ad­dress em­ploy­ee fa­tigue. One em­ploy­ee worked for 14 hours on a fill­ing line, which could lead to man­u­al er­ror on the fill­ing line.

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