ImportRefusal LogoImportRefusal

JIANGSU BOXIN WEI TECHNOLOGY

Low Risk

FEI: 3016866195 • Yangzhou • CHINA

FEI

FEI Number

3016866195

📍

Location

Yangzhou

🇨🇳

Country

CHINA
🏢

Address

8 Hong Chang, , Yangzhou, , China

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/23/2021
Latest Refusal
3/23/2021
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

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.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
3/23/2021
80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE
16DIRECTIONS
333LACKS FIRM
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is JIANGSU BOXIN WEI TECHNOLOGY's FDA import refusal history?

JIANGSU BOXIN WEI TECHNOLOGY (FEI: 3016866195) has 1 FDA import refusal record(s) in our database, spanning from 3/23/2021 to 3/23/2021.

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. JIANGSU BOXIN WEI TECHNOLOGY's FEI number is 3016866195.

What types of violations has JIANGSU BOXIN WEI TECHNOLOGY received?

JIANGSU BOXIN WEI TECHNOLOGY 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 JIANGSU BOXIN WEI TECHNOLOGY come from?

All FDA import refusal data for JIANGSU BOXIN WEI TECHNOLOGY 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.