Not Supplied
⚠️ Moderate Risk
FEI: - • -
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
SALMONELLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2025 | 28BCH13CINNAMON, CASSIA, GROUND, CRACKED (SPICE) | 9SALMONELLA | Division of Northeast Imports (DNEI) |
| 4/10/2014 | 76EFWTOOTHBRUSH, MANUAL | Division of Southeast Imports (DSEI) | |
| 5/12/2010 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | Seattle District Office (SEA-DO) | |
| 6/26/2003 | 90IYBTUBE MOUNT, X-RAY, DIAGNOSTIC | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
| 6/26/2002 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 6/26/2002 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 6/26/2002 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Not Supplied's FDA import refusal history?
Not Supplied (FEI: -) has 7 FDA import refusal record(s) in our database, spanning from 6/26/2002 to 11/3/2025.
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. Not Supplied's FEI number is -.
What types of violations has Not Supplied received?
Not Supplied has been cited for 6 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 Not Supplied come from?
All FDA import refusal data for Not Supplied 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.