# FDA 483 - Eli Lilly & Company - April 23, 2018

Source: https://www.keypedia.com/records/483/eli-lilly-company/bf1c5fc0-d823-410b-bd55-c94c7b67fded

> FDA 483 for Eli Lilly & Company on April 23, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eli Lilly & Company
- Inspection Date: 2018-04-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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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## Related Officers

- [investigator](https://www.keypedia.com/people/corrine-m-carter/69e1be8c-1cd9-48d9-a08e-bf49060b94d6)
- [U.S. Food and Drug Administration](https://www.keypedia.com/people/myra-k-casey/a2fae714-2ba3-4c60-9f54-990fc7b169c9)

Company: https://www.keypedia.com/companies/eli-lilly-company/fc56eed7-d261-4de3-865e-c2aa54162adf

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0