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Skycom Express

Low Risk

FEI: 3003772990 • Safat • KUWAIT

FEI

FEI Number

3003772990

📍

Location

Safat

🇰🇼

Country

KUWAIT
🏢

Address

P.O. Box 1733, , Safat, , Kuwait

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
1/16/2013
Latest Refusal
1/16/2013
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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).

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.

Refusal History

DateProductViolationsDivision
1/16/2013
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
336INCONSPICU
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Skycom Express's FDA import refusal history?

Skycom Express (FEI: 3003772990) has 1 FDA import refusal record(s) in our database, spanning from 1/16/2013 to 1/16/2013.

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. Skycom Express's FEI number is 3003772990.

What types of violations has Skycom Express received?

Skycom Express has been cited for 2 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 Skycom Express come from?

All FDA import refusal data for Skycom Express 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.