Unknown US Manufacturer
⚠️ Moderate Risk
FEI: 3005504875 • Unknown, KY • UNITED STATES
FEI Number
3005504875
Location
Unknown, KY
Country
UNITED STATESAddress
unknown, , Unknown, KY, 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
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/1/2025 | 61PJL74TIRZEPATIDE (ANTI-DIABETIC) | Division of West Coast Imports (DWCI) | |
| 1/23/2006 | 02AGT04POPCORN (NOT POPPED), BULK, WHOLE GRAIN | 320LACKS FIRM | Detroit District Office (DET-DO) |
| 1/23/2006 | 24AGT70LENTILS | 320LACKS FIRM | Detroit District Office (DET-DO) |
| 1/23/2006 | 23KFT03SOYBEANS (EDIBLE SEED) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Unknown US Manufacturer's FDA import refusal history?
Unknown US Manufacturer (FEI: 3005504875) has 4 FDA import refusal record(s) in our database, spanning from 1/23/2006 to 12/1/2025.
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. Unknown US Manufacturer's FEI number is 3005504875.
What types of violations has Unknown US Manufacturer received?
Unknown US Manufacturer 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 Unknown US Manufacturer come from?
All FDA import refusal data for Unknown US Manufacturer 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.