Lovehoney Hampshire
⚠️ Moderate Risk
FEI: 3010458863 • Waterlooville • UNITED KINGDOM
FEI Number
3010458863
Location
Waterlooville
Country
UNITED KINGDOMAddress
Hampshire Cosmetics Waterberry, , Waterlooville, , 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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/24/2017 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 6/23/2015 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 6/23/2015 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 8/15/2014 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Lovehoney Hampshire's FDA import refusal history?
Lovehoney Hampshire (FEI: 3010458863) has 4 FDA import refusal record(s) in our database, spanning from 8/15/2014 to 3/24/2017.
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. Lovehoney Hampshire's FEI number is 3010458863.
What types of violations has Lovehoney Hampshire received?
Lovehoney Hampshire 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 Lovehoney Hampshire come from?
All FDA import refusal data for Lovehoney Hampshire 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.