AbbVie Inc.
🚨 Critical Risk
FEI: 3009751352 • North Chicago, IL • UNITED STATES
FEI Number
3009751352
Location
North Chicago, IL
Country
UNITED STATESAddress
1 N Waukegan Rd, , North Chicago, IL, United States
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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
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).
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.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/14/2025 | 62QCB06UPADACITINIB (ANTI-RHEUMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2025 | 62QCB06UPADACITINIB (ANTI-RHEUMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/13/2025 | 58PCZ05ONABOTULINUMTOXINA | Division of Southeast Imports (DSEI) | |
| 11/10/2025 | 58PDK05ONABOTULINUMTOXINA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/3/2025 | 58MCP09RISANKIZUMAB-RZAA | 179AGR RX | Division of West Coast Imports (DWCI) |
| 10/15/2025 | 58PCY05ONABOTULINUMTOXINA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCP09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCP09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 58MDY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/21/2025 | 62NCL99ANTI-PSORIATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/18/2025 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 62GDY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 58MDY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2025 | 58MDY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2025 | 54YGY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 62NCL99ANTI-PSORIATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 62NCL99ANTI-PSORIATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 58MCK09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 64TDY99IMMUNOSUPPRESS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2025 | 64TDY99IMMUNOSUPPRESS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/27/2024 | 58MCY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 58MDY09RISANKIZUMAB-RZAA | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 58SDY14ADALIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/22/2023 | 66JDA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 179AGR RX | Division of West Coast Imports (DWCI) |
| 11/24/2020 | 62IDL86LEUPROLIDE ACETATE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2017 | 62OCA11TRANDOLAPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/23/2016 | 62VDA37RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is AbbVie Inc.'s FDA import refusal history?
AbbVie Inc. (FEI: 3009751352) has 41 FDA import refusal record(s) in our database, spanning from 12/23/2016 to 12/14/2025.
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. AbbVie Inc.'s FEI number is 3009751352.
What types of violations has AbbVie Inc. received?
AbbVie Inc. has been cited for 4 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.