Overview
- 49 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-09.
At a glance
Inspections
49
Form 483s
12
EIRs
7
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Jan 2026 – 9 Jan 2026 | Human Drugs | Clean | |
| 12 May 2025 – 20 May 2025 | Human Drugs | 483 | View 483 → |
| 24 Mar 2025 – 27 Mar 2025 | Human Drugs | Clean | |
| 6 Jan 2025 – 15 Jan 2025 | Human Drugs | Clean | |
| 2 Oct 2023 – 6 Oct 2023 | Human Drugs | 483 | On file |
| 11 Sep 2023 – 15 Sep 2023 | Human Drugs | 483 | View 483 → |
| 8 Jun 2023 – 16 Jun 2023 | Human Drugs | 483 | On file |
| 15 May 2023 – 18 May 2023 | Medical Devices & Rad Health | Clean | |
| 17 Oct 2022 – 21 Oct 2022 | Human Drugs | 483 | On file |
| 26 Sep 2022 – 30 Sep 2022 | Human Drugs | Clean | |
| 4 Jan 2022 – 13 Jan 2022 | Human Drugs | Clean | |
| 18 Feb 2021 – 16 Mar 2021 | Human Drugs | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
20 May 2025
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Jie He, Rafeeq A Habeeb, Sudipan Karmakar, Jacob G Lutz, Kara J Wright, Scott D Mcgrew
20 May 2025
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Jie He, Rafeeq A Habeeb, Sudipan Karmakar, Jacob G Lutz, Kara J Wright, Scott D Mcgrew
20 May 2025
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jie He, Rafeeq A Habeeb, Sudipan Karmakar, Jacob G Lutz, Kara J Wright, Scott D Mcgrew
20 May 2025
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Jie He, Rafeeq A Habeeb, Sudipan Karmakar, Jacob G Lutz, Kara J Wright, Scott D Mcgrew
20 May 2025
21 CFR 211.84(d)(2)
Establish reliability of supplier's C of A
Cited by Jie He, Rafeeq A Habeeb, Sudipan Karmakar, Jacob G Lutz, Kara J Wright, Scott D Mcgrew
Investigators
FDA investigators tied to this site in the record.
Robert M Barbosa10 insp.
Myra K Casey6 insp.
Corrine M Carter5 insp.
Debara R Reese3 insp.
Patsy J Domingo3 insp.
Rafeeq A Habeeb2 insp.
Dina A Tallman2 insp.
Wayne E Seifert2 insp.
Neali H Lucas2 insp.
Constantin Y Philopoulos2 insp.
Meisha R Sampson2 insp.
Meisha R Waters2 insp.
Michele L Forster2 insp.
Jeffrey D Meng2 insp.
Rebecca E Dombrowski2 insp.
Victoria R Flournoy1 insp.
Jie He1 insp.
Sudipan Karmakar1 insp.
Jacob G Lutz1 insp.
Kara J Wright1 insp.
Scott D Mcgrew1 insp.
Joanne M Schlossin1 insp.
Cara L Alfaro1 insp.
Jennifer A Kemp1 insp.
Melina L Rodriguez-Upton1 insp.
Suyang Qin1 insp.
Michael Shanks1 insp.
Joseph A Piechocki1 insp.
Karen M Montgomery1 insp.
Denise L Burosh1 insp.
Robert J Ham1 insp.
Sandra A Boyd1 insp.
Muna Algharibeh1 insp.
Yangmin Ning1 insp.
Bei Y He1 insp.
Emily J Orban1 insp.
Charles L Zhou1 insp.
Andrace Deyampert1 insp.
Lauren C Iacono-Connors1 insp.
Larry K Austin1 insp.
Byungja E Marciante1 insp.
Donald C Obenhuber1 insp.
Andrea D Swingle1 insp.
Joseph R Strelnik1 insp.
Thomas J Arista1 insp.
Patrick B Cummings1 insp.
David A Paterson1 insp.
Yumi J Hiramine1 insp.
Tina M Pawlowski1 insp.
Ernest Bizjak1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.110(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(1)(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(3)(A) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(3)(B) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(3)(C) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(3)(D) | Cited across public-safe Form 483 observations | 1x |
| FDCA 505-1(f)(3)(F) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Eli Lilly & Company's 12 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat