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ZHEJIANG BADA SPORT INC

✅ Low Risk

FEI: 3016651971 • Jinhua, Zhejiang • CHINA

FEI

FEI Number

3016651971

📍

Location

Jinhua, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

# 88 Jindongqu, Wucheng District, Jinhua, Zhejiang, China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/6/2020
Latest Refusal
8/6/2020
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

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).

Refusal History

DateProductViolationsDivision
8/6/2020
80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE
3280FRNMFGREG
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is ZHEJIANG BADA SPORT INC's FDA import refusal history?

ZHEJIANG BADA SPORT INC (FEI: 3016651971) has 1 FDA import refusal record(s) in our database, spanning from 8/6/2020 to 8/6/2020.

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. ZHEJIANG BADA SPORT INC's FEI number is 3016651971.

What types of violations has ZHEJIANG BADA SPORT INC received?

ZHEJIANG BADA SPORT INC 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 ZHEJIANG BADA SPORT INC come from?

All FDA import refusal data for ZHEJIANG BADA SPORT INC 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.