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Intl Trading Corp Ltd

⚠️ Moderate Risk

FEI: 3003291020 • Charlestown, Nevis • SAINT KITTS AND NEVIS

FEI

FEI Number

3003291020

📍

Location

Charlestown, Nevis

🇰🇳
🏢

Address

PO Box 553, , Charlestown, Nevis, Saint Kitts and Nevis

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
10/12/2004
Latest Refusal
10/12/2004
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

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).

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
10/12/2004
84NFOSTIMULATOR, TRANSCUTANEOUS ELECTRICAL, FOR COSMETIC USE
118NOT LISTED
126FAILS STD
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Intl Trading Corp Ltd's FDA import refusal history?

Intl Trading Corp Ltd (FEI: 3003291020) has 1 FDA import refusal record(s) in our database, spanning from 10/12/2004 to 10/12/2004.

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. Intl Trading Corp Ltd's FEI number is 3003291020.

What types of violations has Intl Trading Corp Ltd received?

Intl Trading Corp Ltd 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 Intl Trading Corp Ltd come from?

All FDA import refusal data for Intl Trading Corp Ltd 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.