Laleham Health & Beauty Limited
⚠️ Moderate Risk
FEI: 3003276300 • Alton, Hampshire • UNITED KINGDOM
FEI Number
3003276300
Location
Alton, Hampshire
Country
UNITED KINGDOMAddress
Sycamore Park, Mill Lane, Alton, Hampshire, 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/9/2025 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | Division of Northern Border Imports (DNBI) | |
| 4/29/2025 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | Division of Northern Border Imports (DNBI) | |
| 9/13/2023 | 60QAY56BENZOCAINE (ANESTHETIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/29/2023 | 60QBY56BENZOCAINE (ANESTHETIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 4/17/2023 | 60QBY56BENZOCAINE (ANESTHETIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/7/2016 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 4/9/2012 | 53BG99OTHER BATH PREPARATIONS, N.E.C. | Baltimore District Office (BLT-DO) | |
| 12/5/2011 | 53BG99OTHER BATH PREPARATIONS, N.E.C. | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Laleham Health & Beauty Limited's FDA import refusal history?
Laleham Health & Beauty Limited (FEI: 3003276300) has 8 FDA import refusal record(s) in our database, spanning from 12/5/2011 to 5/9/2025.
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. Laleham Health & Beauty Limited's FEI number is 3003276300.
What types of violations has Laleham Health & Beauty Limited received?
Laleham Health & Beauty Limited 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 Laleham Health & Beauty Limited come from?
All FDA import refusal data for Laleham Health & Beauty Limited 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.