ImportRefusal LogoImportRefusal

FAR WAY GENERAL TRADING LLC

⚠️ Moderate Risk

FEI: 3013987968 • Dubai • UNITED ARAB EMIRATES

FEI

FEI Number

3013987968

📍

Location

Dubai

🇦🇪
🏢

Address

Next To Jesco Super Market, Nasir Square, Deira Dubai, Dubai, , United Arab Emirates

Moderate Risk

FDA Import Risk Assessment

28.9
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
1/31/2013
Latest Refusal
1/31/2013
Earliest Refusal

Score Breakdown

Violation Severity
54.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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).

3352×

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.

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
1/31/2013
66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
335LACKS N/C
75UNAPPROVED
New Orleans District Office (NOL-DO)
1/31/2013
65LIJ99PROTECTANT N.E.C.
118NOT LISTED
335LACKS N/C
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is FAR WAY GENERAL TRADING LLC's FDA import refusal history?

FAR WAY GENERAL TRADING LLC (FEI: 3013987968) has 2 FDA import refusal record(s) in our database, spanning from 1/31/2013 to 1/31/2013.

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. FAR WAY GENERAL TRADING LLC's FEI number is 3013987968.

What types of violations has FAR WAY GENERAL TRADING LLC received?

FAR WAY GENERAL TRADING LLC 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 FAR WAY GENERAL TRADING LLC come from?

All FDA import refusal data for FAR WAY GENERAL TRADING LLC 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.