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Mohd Hashem Kazem Jewelery

⚠️ Moderate Risk

FEI: 3006370383 • Dubai • UNITED ARAB EMIRATES

FEI

FEI Number

3006370383

📍

Location

Dubai

🇦🇪
🏢

Address

Sikkai Al Khail Road, , Dubai, , United Arab Emirates

Moderate Risk

FDA Import Risk Assessment

31.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
12/5/2011
Latest Refusal
12/5/2011
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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).

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
12/5/2011
53DD02PERFUMES (FRAGRANCE PREPARATIONS)
471CSTIC LBLG
New Orleans District Office (NOL-DO)
12/5/2011
53UH05HAIR PREPARATIONS (NON-COLORING), COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (OTHER)
471CSTIC LBLG
New Orleans District Office (NOL-DO)
12/5/2011
62SBY99ANTI-SEBORRHEIC N.E.C.
118NOT LISTED
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Mohd Hashem Kazem Jewelery's FDA import refusal history?

Mohd Hashem Kazem Jewelery (FEI: 3006370383) has 3 FDA import refusal record(s) in our database, spanning from 12/5/2011 to 12/5/2011.

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. Mohd Hashem Kazem Jewelery's FEI number is 3006370383.

What types of violations has Mohd Hashem Kazem Jewelery received?

Mohd Hashem Kazem Jewelery has been cited for 3 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 Mohd Hashem Kazem Jewelery come from?

All FDA import refusal data for Mohd Hashem Kazem Jewelery 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.