Le West & Co Ltd
⚠️ Moderate Risk
FEI: 3005337019 • Barking • UNITED KINGDOM
FEI Number
3005337019
Location
Barking
Country
UNITED KINGDOMAddress
59-71 River Road, , Barking, , United Kingdom
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/9/2018 | 62GDJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 61TDL04CHLORPROMAZINE HCL (ANTI-EMETIC/NAUSEANT) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 61WDE18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 56EDB80TETRACYCLINE (TETRACYCLINES) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 61ADB06CHLOROQUINE PHOSPHATE (ANTI-AMEBIC) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 64BDL24FUROSEMIDE (DIURETIC) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 60CDL04EPINEPHRINE (ADRENERGIC) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 60QDL70TETRACAINE (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 61PDI10GLUCAGON (ANTI-DIABETIC) | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 66VDD99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 56KDJ10CHLORAMPHENICOL | Division of Northern Border Imports (DNBI) | |
| 1/9/2018 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Le West & Co Ltd's FDA import refusal history?
Le West & Co Ltd (FEI: 3005337019) has 13 FDA import refusal record(s) in our database, spanning from 1/9/2018 to 1/9/2018.
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. Le West & Co Ltd's FEI number is 3005337019.
What types of violations has Le West & Co Ltd received?
Le West & Co Ltd 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 Le West & Co Ltd come from?
All FDA import refusal data for Le West & Co 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.