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

Source: https://www.keypedia.com/records/483/eli-lilly-and-company/553c07c2-b9b2-4a99-9196-a0b1a376f1bc

> 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: FDA District Office — Atlanta, Georgia
- Summary: Eli Lilly and Company in Concord, NC, a sterile drug manufacturer, received a Form 483 with three observations. The inspection revealed deficiencies in process validation for drug products, inadequate validation of sterilization processes for aseptic filling equipment, and insufficient qualification of an automated visual inspection machine for particulate matter. These issues indicate a lack of robust controls to ensure drug product quality and sterility.

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## Related Officers

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

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

Office: https://www.keypedia.com/offices/fda-district-office-atlanta-georgia/bae3b8c4-4161-4e9f-b5d1-e0e80b6abd43