Al Redhak Products Pvt
⚠️ Moderate Risk
FEI: 3007583874 • Dubai • UNITED ARAB EMIRATES
FEI Number
3007583874
Location
Dubai
Country
UNITED ARAB EMIRATESAddress
Plot 101-102 Juamana St Quoz Ind, , 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
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.
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).
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 |
|---|---|---|---|
| 12/8/2015 | 53DY99OTHER FRAGRANCE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/8/2015 | 53CI02EYELINER (EYE MAKEUP PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 12/8/2015 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | Division of Southeast Imports (DSEI) | |
| 12/8/2015 | 53DY99OTHER FRAGRANCE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/5/2014 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 8/5/2014 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 8/5/2014 | 53DY99OTHER FRAGRANCE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Al Redhak Products Pvt's FDA import refusal history?
Al Redhak Products Pvt (FEI: 3007583874) has 7 FDA import refusal record(s) in our database, spanning from 8/5/2014 to 12/8/2015.
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. Al Redhak Products Pvt's FEI number is 3007583874.
What types of violations has Al Redhak Products Pvt received?
Al Redhak Products Pvt 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 Al Redhak Products Pvt come from?
All FDA import refusal data for Al Redhak Products Pvt 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.