Elanco US Inc. dba Elanco Animal Health
⚠️ Moderate Risk
FEI: 1910007 • Fort Dodge, IA • UNITED STATES
FEI Number
1910007
Location
Fort Dodge, IA
Country
UNITED STATESAddress
800 5th St Nw, , Fort Dodge, IA, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/16/2005 | 56BKK16CLOXACILLIN BENZATHINE (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 8/16/2005 | 56BKK29HETACILLIN POTASSIUM (PENICILLIN, SYNTHETICALLY PRODUCED) | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
| 8/16/2005 | 56CKK29CEPHAPIRIN SODIUM (CEPHALOSPORINS) | 27DRUG GMPS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Elanco US Inc. dba Elanco Animal Health's FDA import refusal history?
Elanco US Inc. dba Elanco Animal Health (FEI: 1910007) has 3 FDA import refusal record(s) in our database, spanning from 8/16/2005 to 8/16/2005.
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. Elanco US Inc. dba Elanco Animal Health's FEI number is 1910007.
What types of violations has Elanco US Inc. dba Elanco Animal Health received?
Elanco US Inc. dba Elanco Animal Health has been cited for 1 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 Elanco US Inc. dba Elanco Animal Health come from?
All FDA import refusal data for Elanco US Inc. dba Elanco Animal Health 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.