Lovehoney Ltd
⚠️ Moderate Risk
FEI: 3010683684 • Bath, FN • UNITED KINGDOM
FEI Number
3010683684
Location
Bath, FN
Country
UNITED KINGDOMAddress
100 Locksbrook Road, , Bath, FN, 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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/2/2016 | 80KMJLUBRICANT, PATIENT | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/29/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 8/15/2016 | 80MMSLUBRICANT, VAGINAL, PATIENT | 3280FRNMFGREG | New Orleans District Office (NOL-DO) |
| 8/11/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 8/11/2016 | 85PEBLUBRICANT, PERSONAL, GAMETE, FERTILIZATION, AND EMBRYO COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 8/10/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 8/3/2016 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | New Orleans District Office (NOL-DO) | |
| 2/8/2016 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 2/1/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 1/27/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 11/19/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 3/12/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 1/23/2014 | 78LSTDEVICE, ERECTILE DYSFUNCTION | New Orleans District Office (NOL-DO) | |
| 1/3/2014 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/28/2011 | 80MMSLUBRICANT, VAGINAL, PATIENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Lovehoney Ltd's FDA import refusal history?
Lovehoney Ltd (FEI: 3010683684) has 16 FDA import refusal record(s) in our database, spanning from 10/28/2011 to 9/2/2016.
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 Ltd's FEI number is 3010683684.
What types of violations has Lovehoney Ltd received?
Lovehoney Ltd has been cited for 5 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 Ltd come from?
All FDA import refusal data for Lovehoney 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.