Bathmate Direct
⚠️ Moderate Risk
FEI: 3009608482 • West Yorkshire • UNITED KINGDOM
FEI Number
3009608482
Location
West Yorkshire
Country
UNITED KINGDOMAddress
Units 4-6 Charles St. Mallard, , West Yorkshire, , 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).
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2017 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 7/11/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 3/25/2016 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 1/22/2015 | 80KMJLUBRICANT, PATIENT | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 11/28/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 8/4/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Division of Southeast Imports (DSEI) | |
| 5/23/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 237NO PMA | New Orleans District Office (NOL-DO) |
| 4/2/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 3/14/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 3/12/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 2/7/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 2/3/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 2/3/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 2/3/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 1/28/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 1/14/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 1/3/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 12/18/2013 | 78LSTDEVICE, ERECTILE DYSFUNCTION | New Orleans District Office (NOL-DO) | |
| 12/18/2013 | 79BTAPUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) | New Orleans District Office (NOL-DO) | |
| 12/18/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 11/15/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/8/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 11/8/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 10/2/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 10/2/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 12/14/2012 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) | |
| 8/15/2012 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bathmate Direct's FDA import refusal history?
Bathmate Direct (FEI: 3009608482) has 28 FDA import refusal record(s) in our database, spanning from 8/15/2012 to 3/16/2017.
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. Bathmate Direct's FEI number is 3009608482.
What types of violations has Bathmate Direct received?
Bathmate Direct 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 Bathmate Direct come from?
All FDA import refusal data for Bathmate Direct 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.