ROUGE GARMENTS
⚠️ Moderate Risk
FEI: 3013672704 • Hertfordshire • UNITED KINGDOM
FEI Number
3013672704
Location
Hertfordshire
Country
UNITED KINGDOMAddress
14 Martinfield Business, , Hertfordshire, , 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/19/2018 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/19/2018 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/19/2018 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/11/2018 | 85HDFSPECULUM, VAGINAL, METAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/11/2018 | 78FFQSPECULUM, RECTAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/11/2018 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 10/11/2018 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 10/11/2018 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ROUGE GARMENTS's FDA import refusal history?
ROUGE GARMENTS (FEI: 3013672704) has 8 FDA import refusal record(s) in our database, spanning from 10/11/2018 to 11/19/2018.
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. ROUGE GARMENTS's FEI number is 3013672704.
What types of violations has ROUGE GARMENTS received?
ROUGE GARMENTS has been cited for 2 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 ROUGE GARMENTS come from?
All FDA import refusal data for ROUGE GARMENTS 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.