Euro Gulf Trading
⚠️ Moderate Risk
FEI: 3005064248 • Port Saeed • UNITED ARAB EMIRATES
FEI Number
3005064248
Location
Port Saeed
Country
UNITED ARAB EMIRATESAddress
Abu Baker Siddique Rd, , Port Saeed, , 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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/21/2015 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 7/21/2015 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 10/24/2014 | 53LG99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | Minneapolis District Office (MIN-DO) |
| 10/24/2014 | 53LG99OTHER SKIN CARE PREPARATIONS, N.E.C. | 197COSM COLOR | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Euro Gulf Trading's FDA import refusal history?
Euro Gulf Trading (FEI: 3005064248) has 4 FDA import refusal record(s) in our database, spanning from 10/24/2014 to 7/21/2015.
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. Euro Gulf Trading's FEI number is 3005064248.
What types of violations has Euro Gulf Trading received?
Euro Gulf Trading 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 Euro Gulf Trading come from?
All FDA import refusal data for Euro Gulf 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.