L. E. West & Co.Ltd
⚠️ Moderate Risk
FEI: 3000960831 • London • UNITED KINGDOM
FEI Number
3000960831
Location
London
Country
UNITED KINGDOMAddress
45 Beeby Road, , London, , 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
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/5/2007 | 78GBTCATHETER, RECTAL | New Orleans District Office (NOL-DO) | |
| 3/8/2005 | 61TAB17PROMETHAZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 12/3/2002 | 57IC04DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (MULTIPLE ANTIGEN PREPARATIONS) | New York District Office (NYK-DO) | |
| 11/2/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2002 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is L. E. West & Co.Ltd's FDA import refusal history?
L. E. West & Co.Ltd (FEI: 3000960831) has 5 FDA import refusal record(s) in our database, spanning from 10/17/2002 to 11/5/2007.
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 & Co.Ltd's FEI number is 3000960831.
What types of violations has L. E. West & Co.Ltd received?
L. E. West & Co.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 L. E. West & Co.Ltd come from?
All FDA import refusal data for L. E. 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.