# FDA 483 - Eli Lilly and Company - September 11, 2025

Source: https://www.keypedia.com/records/483/eli-lilly-and-company/f9031c95-8ad0-4123-b05c-2737507e5cf4

> FDA 483 for Eli Lilly and Company on September 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eli Lilly and Company
- Inspection Date: 2025-09-11
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Eli Lilly and Company in Pleasant Prairie, WI, was inspected and received a Form 483 with two observations related to quality control and aseptic processing. The firm failed to thoroughly investigate unexplained discrepancies and lacked adequate procedures to prevent microbiological contamination of sterile drug products. These issues indicate significant concerns regarding the firm's quality system and sterile manufacturing practices.

## Related Officers

- [Tianhong Zhou](https://www.keypedia.com/people/tianhong-zhou/469d9b6b-026a-4c00-b8b9-07e67e96bc22)
- [Melissa M. Steiger](https://www.keypedia.com/people/melissa-m-steiger/513a7364-15df-474f-8a8a-b5c4ff1cf59f)
- [Investigator](https://www.keypedia.com/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.keypedia.com/companies/eli-lilly-and-company/8a6d3dc2-168f-4196-8a63-12b1f113e12a

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d