ImportRefusal LogoImportRefusal

ABC International Limited

⚠️ Moderate Risk

FEI: 3008186223 • Dubai, Dubai • UNITED ARAB EMIRATES

FEI

FEI Number

3008186223

📍

Location

Dubai, Dubai

🇦🇪
🏢

Address

Jebel Ali Free Zone, , Dubai, Dubai, United Arab Emirates

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
3/25/2011
Latest Refusal
3/25/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

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).

Refusal History

DateProductViolationsDivision
3/25/2011
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
118NOT LISTED
Southwest Import District Office (SWI-DO)
3/25/2011
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Southwest Import District Office (SWI-DO)
3/25/2011
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Southwest Import District Office (SWI-DO)
3/25/2011
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is ABC International Limited's FDA import refusal history?

ABC International Limited (FEI: 3008186223) has 4 FDA import refusal record(s) in our database, spanning from 3/25/2011 to 3/25/2011.

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. ABC International Limited's FEI number is 3008186223.

What types of violations has ABC International Limited received?

ABC International Limited has been cited for 1 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 ABC International Limited come from?

All FDA import refusal data for ABC International Limited 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.