# FDA 483 - Eli Lilly & Company - June 16, 2023

Source: https://www.keypedia.com/records/483/eli-lilly-company/ad3d5c22-c165-4f63-91cc-163c31217be2

> FDA 483 for Eli Lilly & Company on June 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eli Lilly & Company
- Inspection Date: 2023-06-16
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Eli Lilly and Company's drug product manufacturing facility in Indianapolis, Indiana, revealed three observations. Deficiencies included failure to follow sanitization procedures for equipment in critical areas, inadequate laboratory practices for test sample traceability, and insufficient validation of sterilization equipment. These issues highlight concerns with adherence to established procedures and validation protocols critical for drug product quality and purity.

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## Related Officers

- [Melina L. Rodriguez-Upton](https://www.keypedia.com/people/melina-l-rodriguez-upton/0b540980-5708-4251-8ea6-6254375506f1)
- [Debara R. Reese](https://www.keypedia.com/people/debara-r-reese/277a8fbb-ba4d-4402-be08-16d7977685db)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

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

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