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Tianjin Suowei Electronic Technology Co., Ltd

⚠️ Moderate Risk

FEI: 3004983300 • Tianjin, Tianjin • CHINA

FEI

FEI Number

3004983300

📍

Location

Tianjin, Tianjin

🇨🇳

Country

CHINA
🏢

Address

2nd Floor, E-1 Building; Nankai Districtno. 6, Zhuyuan Road, Huayuan Industrial, Tianjin, Tianjin, China

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
11/20/2007
Latest Refusal
11/20/2007
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
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

161×

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.

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
11/20/2007
79NRJULTRASOUND, SKIN PERMEATION
16DIRECTIONS
223FALSE
473LABELING
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Tianjin Suowei Electronic Technology Co., Ltd's FDA import refusal history?

Tianjin Suowei Electronic Technology Co., Ltd (FEI: 3004983300) has 1 FDA import refusal record(s) in our database, spanning from 11/20/2007 to 11/20/2007.

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. Tianjin Suowei Electronic Technology Co., Ltd's FEI number is 3004983300.

What types of violations has Tianjin Suowei Electronic Technology Co., Ltd received?

Tianjin Suowei Electronic Technology Co., Ltd has been cited for 3 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 Tianjin Suowei Electronic Technology Co., Ltd come from?

All FDA import refusal data for Tianjin Suowei Electronic Technology Co., Ltd 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.