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Yancheng Foreign Trade Corporation

✅ Low Risk

FEI: 1000574567 • Yancheng, Jiangsu • CHINA

FEI

FEI Number

1000574567

📍

Location

Yancheng, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

13 Dongyanhe Road, Dafeng, Yancheng, Jiangsu, China

Low Risk

FDA Import Risk Assessment

23.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
4
Unique Violations
7/30/2009
Latest Refusal
7/26/2007
Earliest Refusal

Score Breakdown

Violation Severity
43.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
9.9×10%
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

3412×

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).

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

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.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

DateProductViolationsDivision
7/30/2009
75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
7/26/2007
78MSZSTRIP, TEST, REAGENT, RESIDUALS FOR DIALYSATE
333LACKS FIRM
335LACKS N/C
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Yancheng Foreign Trade Corporation's FDA import refusal history?

Yancheng Foreign Trade Corporation (FEI: 1000574567) has 2 FDA import refusal record(s) in our database, spanning from 7/26/2007 to 7/30/2009.

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. Yancheng Foreign Trade Corporation's FEI number is 1000574567.

What types of violations has Yancheng Foreign Trade Corporation received?

Yancheng Foreign Trade Corporation 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 Yancheng Foreign Trade Corporation come from?

All FDA import refusal data for Yancheng Foreign Trade Corporation 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.