Royal Cosmetic Trading
⚠️ Moderate Risk
FEI: 3006693957 • Dubai • UNITED ARAB EMIRATES
FEI Number
3006693957
Location
Dubai
Country
UNITED ARAB EMIRATESAddress
Po Box 39226, , Dubai, , United Arab Emirates
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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.
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 |
|---|---|---|---|
| 6/1/2012 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 9/30/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/23/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/23/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/23/2009 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/23/2009 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/23/2009 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/23/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/23/2009 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/23/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/23/2009 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 9/23/2009 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 9/23/2009 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/23/2009 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Royal Cosmetic Trading's FDA import refusal history?
Royal Cosmetic Trading (FEI: 3006693957) has 14 FDA import refusal record(s) in our database, spanning from 9/23/2009 to 6/1/2012.
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. Royal Cosmetic Trading's FEI number is 3006693957.
What types of violations has Royal Cosmetic Trading received?
Royal Cosmetic Trading 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 Royal Cosmetic Trading come from?
All FDA import refusal data for Royal Cosmetic Trading 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.