Gulf Center For Soap And Chemical Industries
⚠️ Moderate Risk
FEI: 1000413107 • Dubai, Dubai • UNITED ARAB EMIRATES
FEI Number
1000413107
Location
Dubai, Dubai
Country
UNITED ARAB EMIRATESAddress
Po Box 10706, , Dubai, 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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2014 | 86HOISPECTACLE, MAGNIFYING | Division of Southeast Imports (DSEI) | |
| 1/25/2012 | 61HBU99ANTI-BACTERIAL, N.E.C. | 473LABELING | New York District Office (NYK-DO) |
| 1/25/2012 | 61HBU99ANTI-BACTERIAL, N.E.C. | 330UNSAFE COL | New York District Office (NYK-DO) |
| 11/1/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 6/17/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Minneapolis District Office (MIN-DO) |
| 6/17/2008 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 11UNSAFE COL | Minneapolis District Office (MIN-DO) |
| 6/17/2008 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 11UNSAFE COL | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Gulf Center For Soap And Chemical Industries's FDA import refusal history?
Gulf Center For Soap And Chemical Industries (FEI: 1000413107) has 7 FDA import refusal record(s) in our database, spanning from 6/17/2008 to 10/17/2014.
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. Gulf Center For Soap And Chemical Industries's FEI number is 1000413107.
What types of violations has Gulf Center For Soap And Chemical Industries received?
Gulf Center For Soap And Chemical Industries has been cited for 7 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 Gulf Center For Soap And Chemical Industries come from?
All FDA import refusal data for Gulf Center For Soap And Chemical Industries 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.