L E West Ltd
⚠️ High Risk
FEI: 3010276357 • London • UNITED KINGDOM
FEI Number
3010276357
Location
London
Country
UNITED KINGDOMAddress
59 71 River Road, , London, , United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/6/2022 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 75JFMENZYMATIC METHOD, BILIRUBIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 78MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 79EFQSPONGE, GAUZE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 74LDDDC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 73CAOAIRWAY, ESOPHAGEAL (OBTURATOR) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 61PCZ10GLUCAGON (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 64LCJ27FLUOCINOLONE ACETONIDE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 56CCR27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 56ICR76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 60LCN01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 56YDK99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 56YDL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 61RDK15PROTAMINE SULFATE (ANTIDOTE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 61LCL29ENOXAPARIN SODIUM (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 64LCQ02BECLOMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 61KCP25HYOSCYAMINE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 61KCP25HYOSCYAMINE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 64LCY56PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 60QCK52TETRACAINE HCL (ANESTHETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 56YDK99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 64LCM38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 63NCK21PILOCARPINE HCL (CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 62KCE08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 66FCA05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 62GCY49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 63BCQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2022 | 60CCP04EPINEPHRINE (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/19/2020 | 74LDDDC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/19/2020 | 62GCY49NAPROXEN (ANTI-INFLAMMATORY) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/14/2018 | 60CCP02DOPAMINE HCL (ADRENERGIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/14/2018 | 61WCJ47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/14/2018 | 62KCE08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/14/2018 | 61PCZ10GLUCAGON (ANTI-DIABETIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/14/2018 | 61FCA54CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/14/2018 | 63BCQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/14/2018 | 65RCP14POTASSIUM CHLORIDE (REPLENISHER) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is L E West Ltd's FDA import refusal history?
L E West Ltd (FEI: 3010276357) has 38 FDA import refusal record(s) in our database, spanning from 6/14/2018 to 1/6/2022.
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. L E West Ltd's FEI number is 3010276357.
What types of violations has L E West Ltd received?
L E West Ltd has been cited for 3 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 L E West Ltd come from?
All FDA import refusal data for L E West 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.