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Yiwu Foreign Economic Relations Trading Co.

⚠️ Moderate Risk

FEI: 3001106709 • Zhejiang • CHINA

FEI

FEI Number

3001106709

📍

Location

Zhejiang

🇨🇳

Country

CHINA
🏢

Address

350 Middle Chouzou Road, , Zhejiang, , China

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

9
Total Refusals
4
Unique Violations
4/12/2004
Latest Refusal
1/13/2003
Earliest Refusal

Score Breakdown

Violation Severity
52.3×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
72.2×10%
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

4765×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

1183×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3413×

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).

472×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
4/12/2004
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)
7/8/2003
95L22LASER PRODUCT FOR NON-MEDICAL USE
47NON STD
New York District Office (NYK-DO)
1/14/2003
95L22LASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
New York District Office (NYK-DO)
1/14/2003
95L22LASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
New York District Office (NYK-DO)
1/14/2003
95L22LASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
New York District Office (NYK-DO)
1/14/2003
95L22LASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
New York District Office (NYK-DO)
1/14/2003
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)
1/14/2003
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
New York District Office (NYK-DO)
1/13/2003
95L22LASER PRODUCT FOR NON-MEDICAL USE
47NON STD
476NO REGISTR
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Yiwu Foreign Economic Relations Trading Co.'s FDA import refusal history?

Yiwu Foreign Economic Relations Trading Co. (FEI: 3001106709) has 9 FDA import refusal record(s) in our database, spanning from 1/13/2003 to 4/12/2004.

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. Yiwu Foreign Economic Relations Trading Co.'s FEI number is 3001106709.

What types of violations has Yiwu Foreign Economic Relations Trading Co. received?

Yiwu Foreign Economic Relations Trading Co. 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 Yiwu Foreign Economic Relations Trading Co. come from?

All FDA import refusal data for Yiwu Foreign Economic Relations Trading Co. 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.