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SHENZHEN COOL SONIC TECHNOLOGY C

Low Risk

FEI: 3017085048 • Shenzhen • CHINA

FEI

FEI Number

3017085048

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

6/F Bld 1 Fujinshun Ind, , Shenzhen, , China

Low Risk

FDA Import Risk Assessment

21.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
5/17/2021
Latest Refusal
5/17/2021
Earliest Refusal

Score Breakdown

Violation Severity
42.5×40%
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

38421×

TP NO PMTA

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C Act in that it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act.

38431×

TP NO SE

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).

38511×

TPLACKFIRM

This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor.

38541×

TPLKUSSLLB

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.

Refusal History

DateProductViolationsDivision
5/17/2021
98LAA02E-CIGARETTE, KIT
3842TP NO PMTA
3843TP NO SE
3851TPLACKFIRM
3854TPLKUSSLLB
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is SHENZHEN COOL SONIC TECHNOLOGY C's FDA import refusal history?

SHENZHEN COOL SONIC TECHNOLOGY C (FEI: 3017085048) has 1 FDA import refusal record(s) in our database, spanning from 5/17/2021 to 5/17/2021.

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. SHENZHEN COOL SONIC TECHNOLOGY C's FEI number is 3017085048.

What types of violations has SHENZHEN COOL SONIC TECHNOLOGY C received?

SHENZHEN COOL SONIC TECHNOLOGY C 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 SHENZHEN COOL SONIC TECHNOLOGY C come from?

All FDA import refusal data for SHENZHEN COOL SONIC TECHNOLOGY C 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.