# FDA 483 - Eli Lilly & Company - October 06, 2023

Source: https://www.globalkeysolutions.net/records/483/eli-lilly-company/f0349542-8a47-4147-9164-7ecacf1fcd4e

> FDA 483 for Eli Lilly & Company on October 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eli Lilly & Company
- Inspection Date: 2023-10-06
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Eli Lilly and Company in Indianapolis, Indiana, received a Form 483 with three observations related to sterile drug product manufacturing. The observations highlight deficiencies in preventing microbiological contamination, inadequate sterilization process validation, and an unoptimized drug product fill process leading to encrustation. These issues indicate significant concerns regarding aseptic processing and product quality control.

## Related Documents

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- [EIR - 2023-05-18](https://www.globalkeysolutions.net/records/eir/eli-lilly-company/15f9ed35-a475-4557-b1f2-753ea60f17a2)
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- [483 - 2025-05-20](https://www.globalkeysolutions.net/records/483/eli-lilly-company/885fecd9-f6cd-48fd-90eb-66d12ec35d07)

## Related Officers

- [Qiao Y. Bobo](https://www.globalkeysolutions.net/people/qiao-y-bobo/c57c1128-9181-4c2a-81f9-cb9a171ece38)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd