Lilly Usa, Llc.
⚠️ Moderate Risk
FEI: 3010711893 • Indianapolis, IN • UNITED STATES
FEI Number
3010711893
Location
Indianapolis, IN
Country
UNITED STATESAddress
228 E Mccarty 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
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.
AGRINSULIN
The article appears to be composed wholly or partly of insulin manufactured in the US and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for a medical emergency
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/4/2014 | 61P17INSULIN (INJ) (ANTI-DIABETIC) | Florida District Office (FLA-DO) | |
| 4/4/2014 | 61P17INSULIN (INJ) (ANTI-DIABETIC) | Florida District Office (FLA-DO) | |
| 4/4/2014 | 61P17INSULIN (INJ) (ANTI-DIABETIC) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Lilly Usa, Llc.'s FDA import refusal history?
Lilly Usa, Llc. (FEI: 3010711893) has 3 FDA import refusal record(s) in our database, spanning from 4/4/2014 to 4/4/2014.
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. Lilly Usa, Llc.'s FEI number is 3010711893.
What types of violations has Lilly Usa, Llc. received?
Lilly Usa, Llc. has been cited for 2 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 Lilly Usa, Llc. come from?
All FDA import refusal data for Lilly Usa, Llc. 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.