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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