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WARIS IBTISAM

⚠️ Moderate Risk

FEI: 3035250870 • Dubai, Dubai • UNITED ARAB EMIRATES

FEI

FEI Number

3035250870

📍

Location

Dubai, Dubai

🇦🇪
🏢

Address

C/O Linehaul Express Llc, Dubai; Dubai - Al Ain Rd, Dubai, Dubai, United Arab Emirates

Moderate Risk

FDA Import Risk Assessment

34.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
5
Unique Violations
3/12/2025
Latest Refusal
3/12/2025
Earliest Refusal

Score Breakdown

Violation Severity
34.0×40%
Refusal Volume
11.2×30%
Recency
83.3×20%
Frequency
10.0×10%
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

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.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
3/12/2025
61WDJ45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
333LACKS FIRM
335LACKS N/C
336INCONSPICU
472NO ENGLISH
473LABELING
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is WARIS IBTISAM's FDA import refusal history?

WARIS IBTISAM (FEI: 3035250870) has 1 FDA import refusal record(s) in our database, spanning from 3/12/2025 to 3/12/2025.

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. WARIS IBTISAM's FEI number is 3035250870.

What types of violations has WARIS IBTISAM received?

WARIS IBTISAM 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 WARIS IBTISAM come from?

All FDA import refusal data for WARIS IBTISAM 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.