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Ct Forwarder Limited

⚠️ Moderate Risk

FEI: 3008048936 • Shenzhen • CHINA

FEI

FEI Number

3008048936

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

Xinxintian Industrial Park, , Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

29.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
1/14/2010
Latest Refusal
1/14/2010
Earliest Refusal

Score Breakdown

Violation Severity
62.5×40%
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

1171×

DANGEROUS

The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.

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).

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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
1/14/2010
89MZXSTIMULATOR, ELECTRICAL FOR SMOKING CESSATION
117DANGEROUS
118NOT LISTED
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Ct Forwarder Limited's FDA import refusal history?

Ct Forwarder Limited (FEI: 3008048936) has 1 FDA import refusal record(s) in our database, spanning from 1/14/2010 to 1/14/2010.

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. Ct Forwarder Limited's FEI number is 3008048936.

What types of violations has Ct Forwarder Limited received?

Ct Forwarder Limited has been cited for 4 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 Ct Forwarder Limited come from?

All FDA import refusal data for Ct Forwarder 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.