WELL-LEAD TRADING CO., LTD

⚠️ Moderate Risk

FEI: 3006946044 • Shanghaishi, Shanghaishi • CHINA

FEI

FEI Number

3006946044

📍

Location

Shanghaishi, Shanghaishi

🇨🇳

Country

CHINA

🏢

Address

Mansion 19 Lancunlu, 1381 DONGFANG ROAD, Shanghaishi, Shanghaishi, China

Moderate Risk

FDA Import Risk Assessment

43.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/13/2006

Latest Refusal

12/13/2006

Earliest Refusal

Score Breakdown

Violation Severity

52.7×40%

Refusal Volume

40.0×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

50811×

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.

3419×

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).

4762×

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).

Refusal History

Date	Product	Violations	Division
12/13/2006	80LEYSET, ORAL AMINISTRATION	476NO REGISTR 508NO 510(K)	Los Angeles District Office (LOS-DO)
12/13/2006	80LEYSET, ORAL AMINISTRATION	476NO REGISTR 508NO 510(K)	Los Angeles District Office (LOS-DO)
12/13/2006	80LEYSET, ORAL AMINISTRATION	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
12/13/2006	80LEYSET, ORAL AMINISTRATION	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
12/13/2006	80LEYSET, ORAL AMINISTRATION	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
12/13/2006	80LEYSET, ORAL AMINISTRATION	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
12/13/2006	80LEYSET, ORAL AMINISTRATION	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
12/13/2006	80LEYSET, ORAL AMINISTRATION	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
12/13/2006	80LEYSET, ORAL AMINISTRATION	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
12/13/2006	80LEYSET, ORAL AMINISTRATION	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)
12/13/2006	80LEYSET, ORAL AMINISTRATION	341REGISTERED 508NO 510(K)	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is WELL-LEAD TRADING CO., LTD's FDA import refusal history?

WELL-LEAD TRADING CO., LTD (FEI: 3006946044) has 11 FDA import refusal record(s) in our database, spanning from 12/13/2006 to 12/13/2006.

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. WELL-LEAD TRADING CO., LTD's FEI number is 3006946044.

What types of violations has WELL-LEAD TRADING CO., LTD received?

WELL-LEAD 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 WELL-LEAD TRADING CO., LTD come from?

All FDA import refusal data for WELL-LEAD 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.