Lovehoney Gopaldas
⚠️ High Risk
FEI: 3011528338 • Tsim Sha Tsui, Kowloon • HONG KONG
FEI Number
3011528338
Location
Tsim Sha Tsui, Kowloon
Country
HONG KONGAddress
Empire Centre, 68 Mody Rd., Tsim Sha Tsui, Kowloon, Hong Kong
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
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.
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.
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 |
|---|---|---|---|
| 8/17/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/3/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 7/11/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 6/7/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 5/27/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 5/23/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 5/23/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 5/23/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 5/20/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 5/9/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 4/18/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 4/8/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 4/8/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 4/8/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 4/1/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 4/1/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 3/16/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 3/16/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 3/11/2016 | 78LSTDEVICE, ERECTILE DYSFUNCTION | New Orleans District Office (NOL-DO) | |
| 3/10/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 2/23/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 2/12/2016 | 78FJXRING, CRIMP | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/27/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 1/25/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 1/25/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 12/10/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 12/9/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 12/1/2015 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 12/1/2015 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 10/30/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 10/13/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/22/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/22/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 9/10/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 8/20/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Lovehoney Gopaldas's FDA import refusal history?
Lovehoney Gopaldas (FEI: 3011528338) has 35 FDA import refusal record(s) in our database, spanning from 8/20/2015 to 8/17/2016.
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 Gopaldas's FEI number is 3011528338.
What types of violations has Lovehoney Gopaldas received?
Lovehoney Gopaldas 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 Gopaldas come from?
All FDA import refusal data for Lovehoney Gopaldas 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.