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Creative International Concepts

⚠️ Moderate Risk

FEI: 3009576273 • Hong Konghong Kong • HONG KONG

FEI

FEI Number

3009576273

📍

Location

Hong Konghong Kong

🇭🇰

Country

HONG KONG
🏢

Address

245-251 Hennessy Rdroom A 6th Floor, , Hong Konghong Kong, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/14/2013
Latest Refusal
6/14/2013
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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).

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

Refusal History

DateProductViolationsDivision
6/14/2013
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
118NOT LISTED
235NOT IMPACT
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Creative International Concepts's FDA import refusal history?

Creative International Concepts (FEI: 3009576273) has 1 FDA import refusal record(s) in our database, spanning from 6/14/2013 to 6/14/2013.

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. Creative International Concepts's FEI number is 3009576273.

What types of violations has Creative International Concepts received?

Creative International Concepts 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 Creative International Concepts come from?

All FDA import refusal data for Creative International Concepts 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.