Emirates Refining Company
⚠️ Moderate Risk
FEI: 3002722300 • Shah, Abu Dhabi • UNITED ARAB EMIRATES
FEI Number
3002722300
Location
Shah, Abu Dhabi
Country
UNITED ARAB EMIRATESAddress
Po Box 6906, , Shah, Abu Dhabi, 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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/20/2016 | 79LRRKIT, FIRST AID | Division of West Coast Imports (DWCI) | |
| 7/20/2016 | 79LRRKIT, FIRST AID | Division of West Coast Imports (DWCI) | |
| 7/20/2016 | 79LRRKIT, FIRST AID | Division of West Coast Imports (DWCI) | |
| 7/20/2016 | 79LRRKIT, FIRST AID | Division of West Coast Imports (DWCI) | |
| 7/20/2016 | 79LRRKIT, FIRST AID | Division of West Coast Imports (DWCI) | |
| 7/20/2016 | 79LRRKIT, FIRST AID | Division of West Coast Imports (DWCI) | |
| 7/20/2016 | 79LRRKIT, FIRST AID | Division of West Coast Imports (DWCI) | |
| 7/20/2016 | 79LRRKIT, FIRST AID | Division of West Coast Imports (DWCI) | |
| 9/26/2012 | 76EFWTOOTHBRUSH, MANUAL | New York District Office (NYK-DO) | |
| 5/19/2012 | 85HEBTAMPON, MENSTRUAL, UNSCENTED | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 12/6/2010 | 76EFWTOOTHBRUSH, MANUAL | New York District Office (NYK-DO) | |
| 12/6/2010 | 63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/13/2005 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/5/2003 | 54YCB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Emirates Refining Company's FDA import refusal history?
Emirates Refining Company (FEI: 3002722300) has 14 FDA import refusal record(s) in our database, spanning from 12/5/2003 to 7/20/2016.
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. Emirates Refining Company's FEI number is 3002722300.
What types of violations has Emirates Refining Company received?
Emirates Refining Company 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 Emirates Refining Company come from?
All FDA import refusal data for Emirates Refining Company 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.