Abbott International
⚠️ Moderate Risk
FEI: 3003015083 • Abbott Park, IL • UNITED STATES
FEI Number
3003015083
Location
Abbott Park, IL
Country
UNITED STATESAddress
200 Abbott Park Rd, , Abbott Park, 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
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).
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 |
|---|---|---|---|
| 4/4/2018 | 66JCA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/24/2005 | 62FAK47CARBAMIDE PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/24/2005 | 60CAK46NAPHAZOLINE HCL (ADRENERGIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/6/2005 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 342PERSONALRX | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Abbott International's FDA import refusal history?
Abbott International (FEI: 3003015083) has 4 FDA import refusal record(s) in our database, spanning from 1/6/2005 to 4/4/2018.
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 International's FEI number is 3003015083.
What types of violations has Abbott International received?
Abbott International has been cited for 3 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 International come from?
All FDA import refusal data for Abbott International 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.