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AL HARAMAIN PERFUMES

⚠️ Moderate Risk

FEI: 3012405717 • Dubai • UNITED ARAB EMIRATES

FEI

FEI Number

3012405717

📍

Location

Dubai

🇦🇪
🏢

Address

Murshid Bazar Deira, , Dubai, , United Arab Emirates

Moderate Risk

FDA Import Risk Assessment

27.2
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
5
Unique Violations
10/17/2014
Latest Refusal
3/8/2013
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
18.6×10%
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

4712×

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.

1181×

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).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

751×

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

DateProductViolationsDivision
10/17/2014
53DY02PERFUMES (FRAGRANCE PREPARATIONS)
471CSTIC LBLG
Division of Southeast Imports (DSEI)
6/30/2014
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
474COSMETLBLG
New Orleans District Office (NOL-DO)
3/8/2013
63VBY99DEPIGMENTOR N.E.C.
118NOT LISTED
333LACKS FIRM
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is AL HARAMAIN PERFUMES's FDA import refusal history?

AL HARAMAIN PERFUMES (FEI: 3012405717) has 3 FDA import refusal record(s) in our database, spanning from 3/8/2013 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. AL HARAMAIN PERFUMES's FEI number is 3012405717.

What types of violations has AL HARAMAIN PERFUMES received?

AL HARAMAIN PERFUMES 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 HARAMAIN PERFUMES come from?

All FDA import refusal data for AL HARAMAIN PERFUMES 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.