# FDA 483 - Eli Lilly and Company - February 11, 2026

Source: https://www.keypedia.com/records/483/eli-lilly-and-company/84443bff-5400-4166-af30-dea318ec4b7a

> FDA 483 for Eli Lilly and Company on February 11, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eli Lilly and Company
- Inspection Date: 2026-02-11
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Eli Lilly and Company in Concord, NC, a sterile drug manufacturer, received a Form 483 with three observations during an FDA inspection. The firm was cited for failing to establish adequate written procedures for process validation across all drug product strengths and for lacking proper validation of aseptic and sterilization processes. Additionally, the firm did not adequately qualify an automated visual inspection machine used for in-process controls, indicating significant deficiencies in their manufacturing and quality control systems.

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## Related Officers

- [Rose L. Jean-Mary](https://www.keypedia.com/people/rose-l-jean-mary/398483f5-12f7-429b-8a13-c068b41ff3ed)
- [Young K. Chou](https://www.keypedia.com/people/young-k-chou/3f34cb70-7f30-453d-9099-885e1b168975)
- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.keypedia.com/companies/eli-lilly-and-company/3ee60880-ca28-4c3e-a630-512617af2daa

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7