Abbott Diagnostics
⚠️ Moderate Risk
FEI: 3003128095 • Abbott Park, IL • UNITED STATES
FEI Number
3003128095
Location
Abbott Park, IL
Country
UNITED STATESAddress
One Abbott Park Road, , 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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/14/2007 | 75CECRADIOIMMUNOASSAY, FREE THYROXINE | New Orleans District Office (NOL-DO) | |
| 12/14/2007 | 75CDXRADIOIMMUNOASSAY, TOTAL THYROXINE | New Orleans District Office (NOL-DO) | |
| 12/14/2007 | 75JJIANALYZER, ENZYME, FOR CLINICAL USE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Abbott Diagnostics's FDA import refusal history?
Abbott Diagnostics (FEI: 3003128095) has 3 FDA import refusal record(s) in our database, spanning from 12/14/2007 to 12/14/2007.
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 Diagnostics's FEI number is 3003128095.
What types of violations has Abbott Diagnostics received?
Abbott Diagnostics 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 Diagnostics come from?
All FDA import refusal data for Abbott Diagnostics 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.