AbbVie Inc.
⚠️ High Risk
FEI: 1411365 • North Chicago, IL • UNITED STATES
FEI Number
1411365
Location
North Chicago, IL
Country
UNITED STATESAddress
1401 Sheridan Rd, , North Chicago, IL, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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 |
|---|---|---|---|
| 11/3/2025 | 58SCP14ADALIMUMAB | 179AGR RX | Division of West Coast Imports (DWCI) |
| 2/22/2024 | 62ICK86LEUPROLIDE ACETATE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2023 | 65QCY02BOTOX | Division of West Coast Imports (DWCI) | |
| 1/21/2002 | 64GJP08ESTRADIOL BENZOATE (ESTROGEN) | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is AbbVie Inc.'s FDA import refusal history?
AbbVie Inc. (FEI: 1411365) has 4 FDA import refusal record(s) in our database, spanning from 1/21/2002 to 11/3/2025.
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. AbbVie Inc.'s FEI number is 1411365.
What types of violations has AbbVie Inc. received?
AbbVie Inc. 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 AbbVie Inc. come from?
All FDA import refusal data for AbbVie Inc. 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.