Eli Lilly and Company
FDA inspection history across 5 sites, 2001 to 2025
- 8
- Form 483s
- 3
- Responses
- 2
- Warning letters
- 2
- EIRs
Every document, by year
- Warning letter
- Form 483
- Response
- EIR
2001: two 483 responses, one warning letter and one Form 483; 2018: one Form 483; 2020: two inspection reports; 2021: one 483 response and one Form 483; 2022: one Form 483; 2023: three Form 483s; 2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2001Two 483 responses, one warning letter and one Form 483, at Indianapolis, Indiana and Detroit, Michigan.
- 2001The longest 483 on file: 20 observations over 25 pages at Indianapolis, Indiana.
- 2018–25Seven Form 483s, two inspection reports, one 483 response and one warning letter, at Indianapolis, Indiana; Indiana; I ndianapol i s, Indiana and one other site.
Cited most
Across all Eli Lilly and observations on file
- 21 CFR 211.113Control of microbiological contamination14
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160General requirements3
- 21 CFR 211.188Batch production and control records3
- 21 CFR 211.192Production record review3
The complete Eli Lilly and file.
All 15 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Indianapolis, Indiana
Six Form 483s, two warning letters, two inspection reports and one 483 response · 2001 to 2025 · 38 observations
Latest: Warning letter, Sep 9, 2025 →. Indianapolis, Indiana
One Form 483 · 2023 · 3 observations
Latest: Form 483, Jun 16, 2023 →Indiana
One 483 response · 2021
Latest: Response, Apr 6, 2021 →I ndianapol i s, Indiana
One Form 483 · 2021 · 7 observations
Latest: Form 483, Mar 16, 2021 →Detroit, Michigan
One 483 response · 2001
Latest: Response, Mar 8, 2001 →
Documents
15 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-09 | Warning letter Warning letter | Indianapolis, Indiana | — | $99 |
| 2025-05-20 | 483 Form 483 | Indianapolis, Indiana | 6 | $99 |
| 2023-10-06 | 483 Form 483 | Indianapolis, Indiana | 3 | $99 |
| 2023-09-15 | 483 Form 483 | Indianapolis, Indiana | 5 | $99 |
| 2023-06-16 | 483 Form 483 | . Indianapolis, Indiana | 3 | $99 |
| 2022-10-21 | 483 Form 483 | Indianapolis, Indiana | 3 | $99 |
| 2021-04-06 | Response 483 response | Indiana | — | $199 |
| 2021-03-16 | 483 Form 483 | I ndianapol i s, Indiana | 7 | $99 |
| 2020-03-20 | EIR EIR | Indianapolis, Indiana | — | $550 |
| 2020-01-17 | EIR EIR | Indianapolis, Indiana | — | $550 |
| 2018-04-23 | 483 Form 483 | Indianapolis, Indiana | 1 | $99 |
| 2001-03-08 | Response 483 response | Indianapolis, Indiana | — | $199 |
| 2001-03-08 | Response 483 response | Detroit, Michigan | — | $199 |
| 2001-03-02 | Warning letter Warning letter | Indianapolis, Indiana | — | $99 |
| 2001-02-23 | 483 Form 483 | Indianapolis, Indiana | 20 | $99 |
Investigators on these documents
Myra K. Casey (3)Patricia A. Cochran (3)Jeffrey A. Sommers (2)Thomas J. Arista (2)Wayne Seifert (2)Junho Pak (1)Kara J. Wright (1)Melina Rodriguez Upton (1)Mercy Oyugi (1)Michael R. Shanks (1)Michael T. Cyrus (1)Corrine M. Carter (1)
FEI number 1819470 · most recent document Sep 9, 2025
About Eli Lilly and Company
How many FDA Form 483s has Eli Lilly and Company received?
FDA Intel has 8 Form 483s on file for Eli Lilly and Company; the most recent is dated May 20, 2025.
When was Eli Lilly and Company last inspected by FDA?
The most recent FDA inspection document on file for Eli Lilly and Company is a Form 483 dated May 20, 2025, for the site in Indianapolis, Indiana.
What did FDA cite at Eli Lilly and Company?
The regulations cited most in the observations on file for Eli Lilly and Company are 21 CFR 211.113 (Control of microbiological contamination), 14 times; 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.160 (General requirements), 3 times.
Has Eli Lilly and Company received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Eli Lilly and Company; the most recent is dated Sep 9, 2025.