B4u Ltd
⚠️ Moderate Risk
FEI: 3004187343 • Azur • ISRAEL
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
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 |
|---|---|---|---|
| 6/27/2014 | 53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 6/27/2014 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | Cincinnati District Office (CIN-DO) | |
| 10/19/2004 | 53UC13SUNTAN PREPARATIONS, COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER ANIMAL BY-PRODUCTS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is B4u Ltd's FDA import refusal history?
B4u Ltd (FEI: 3004187343) has 3 FDA import refusal record(s) in our database, spanning from 10/19/2004 to 6/27/2014.
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. B4u Ltd's FEI number is 3004187343.
What types of violations has B4u Ltd received?
B4u Ltd 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 B4u Ltd come from?
All FDA import refusal data for B4u Ltd 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.