483
Eli Lilly & CompanyFDA 483 - Eli Lilly & Company - April 23, 2018
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Record Details
Eli Lilly and Company in Indianapolis, IN, was inspected regarding its Pharmacovigilance and REMS processes. The inspection revealed that the firm failed to submit all required adverse drug experience reports within the mandated 30-day timeframe for several drug applications. This indicates a significant delay in reporting critical safety information to the FDA.
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ID · bf1c5fc0-d823-410b-bd55-c94c7b67fded