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Shenzhen E-Cikar Ele&Tech

⚠️ High Risk

FEI: 3008462231 • Shenzhenshenzhen • CHINA

FEI

FEI Number

3008462231

📍

Location

Shenzhenshenzhen

🇨🇳

Country

CHINA
🏢

Address

5a Aoweili Ind Park Gonghecommunity, , Shenzhenshenzhen, , China

High Risk

FDA Import Risk Assessment

50.6
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

8
Total Refusals
2
Unique Violations
11/16/2010
Latest Refusal
11/16/2010
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

168×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

758×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
11/16/2010
66BAY44NICOTINE DELIVERY SYSTEM
16DIRECTIONS
75UNAPPROVED
Seattle District Office (SEA-DO)
11/16/2010
66BAY44NICOTINE DELIVERY SYSTEM
16DIRECTIONS
75UNAPPROVED
Seattle District Office (SEA-DO)
11/16/2010
80MSNCIGARETTES (CONTAINING TOBACCO)
16DIRECTIONS
75UNAPPROVED
Seattle District Office (SEA-DO)
11/16/2010
80MSNCIGARETTES (CONTAINING TOBACCO)
16DIRECTIONS
75UNAPPROVED
Seattle District Office (SEA-DO)
11/16/2010
66BAY44NICOTINE DELIVERY SYSTEM
16DIRECTIONS
75UNAPPROVED
Seattle District Office (SEA-DO)
11/16/2010
66BAY44NICOTINE DELIVERY SYSTEM
16DIRECTIONS
75UNAPPROVED
Seattle District Office (SEA-DO)
11/16/2010
66BAY44NICOTINE DELIVERY SYSTEM
16DIRECTIONS
75UNAPPROVED
Seattle District Office (SEA-DO)
11/16/2010
66BAY44NICOTINE DELIVERY SYSTEM
16DIRECTIONS
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Shenzhen E-Cikar Ele&Tech's FDA import refusal history?

Shenzhen E-Cikar Ele&Tech (FEI: 3008462231) has 8 FDA import refusal record(s) in our database, spanning from 11/16/2010 to 11/16/2010.

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. Shenzhen E-Cikar Ele&Tech's FEI number is 3008462231.

What types of violations has Shenzhen E-Cikar Ele&Tech received?

Shenzhen E-Cikar Ele&Tech 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 Shenzhen E-Cikar Ele&Tech come from?

All FDA import refusal data for Shenzhen E-Cikar Ele&Tech 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.