Abbott Laboratories
⚠️ Moderate Risk
FEI: 1451914 • North Chicago, IL • UNITED STATES
FEI Number
1451914
Location
North Chicago, IL
Country
UNITED STATESAddress
3158 Martin Luther King Jr Dr, , North Chicago, IL, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/23/2012 | 62OCA10TERAZOSIN HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/10/2011 | 64GDA29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/10/2011 | 62ICK86LEUPROLIDE ACETATE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/10/2011 | 64GCA07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/4/2009 | 66JCY01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/21/2008 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/29/2007 | 61JIY99ANTI-CHOLESTEREMIC, N.E.C. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 5/25/2006 | 62VCE37RITONAVIR (ANTI-VIRAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/17/2006 | 60QCK40LIDOCAINE HCL (ANESTHETIC) | 179AGR RX | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Abbott Laboratories's FDA import refusal history?
Abbott Laboratories (FEI: 1451914) has 9 FDA import refusal record(s) in our database, spanning from 1/17/2006 to 4/23/2012.
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. Abbott Laboratories's FEI number is 1451914.
What types of violations has Abbott Laboratories received?
Abbott Laboratories 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 Abbott Laboratories come from?
All FDA import refusal data for Abbott Laboratories 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.