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Yangzhou Long Kang Trading Co Ltd

✅ Low Risk

FEI: 3011766309 • Shaobei, Yangzhou • CHINA

FEI

FEI Number

3011766309

📍

Location

Shaobei, Yangzhou

🇨🇳

Country

CHINA
🏢

Address

Xiezhuang CUN, , Shaobei, Yangzhou, China

Low Risk

FDA Import Risk Assessment

19.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
9/18/2015
Latest Refusal
9/18/2015
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
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

1181×

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).

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
9/18/2015
79MCATAPE, SURGICAL, INTERNAL
118NOT LISTED
333LACKS FIRM
335LACKS N/C
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Yangzhou Long Kang Trading Co Ltd's FDA import refusal history?

Yangzhou Long Kang Trading Co Ltd (FEI: 3011766309) has 1 FDA import refusal record(s) in our database, spanning from 9/18/2015 to 9/18/2015.

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. Yangzhou Long Kang Trading Co Ltd's FEI number is 3011766309.

What types of violations has Yangzhou Long Kang Trading Co Ltd received?

Yangzhou Long Kang Trading 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 Yangzhou Long Kang Trading Co Ltd come from?

All FDA import refusal data for Yangzhou Long Kang Trading 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.