Eli Lilly
⚠️ Moderate Risk
FEI: 3005720260 • Indianapolis, IN • UNITED STATES
FEI Number
3005720260
Location
Indianapolis, IN
Country
UNITED STATESAddress
1400 W Raymond St, , Indianapolis, IN, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2025 | 61PCP54LISPRO INSULIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 8/11/2008 | 61LIA99ANTI-COAGULANT, N.E.C. | Detroit District Office (DET-DO) | |
| 11/20/2003 | 66NCB02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Eli Lilly's FDA import refusal history?
Eli Lilly (FEI: 3005720260) has 3 FDA import refusal record(s) in our database, spanning from 11/20/2003 to 11/14/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Eli Lilly's FEI number is 3005720260.
What types of violations has Eli Lilly received?
Eli Lilly has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Eli Lilly come from?
All FDA import refusal data for Eli Lilly is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.