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WUHAN TOPMED TRADING CO. LTD.

⚠️ Moderate Risk

FEI: 3022082641 • Wuhan • CHINA

FEI

FEI Number

3022082641

📍

Location

Wuhan

🇨🇳

Country

CHINA
🏢

Address

Block D 1904, No. 147 South Luoshi Rd, Hongshan; Future City, Wuhan, , China

Moderate Risk

FDA Import Risk Assessment

30.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/25/2022
Latest Refusal
4/25/2022
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
11.7×20%
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).

5081×

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.

Refusal History

DateProductViolationsDivision
4/25/2022
80MMPCOVER, BARRIER, PROTECTIVE
118NOT LISTED
508NO 510(K)
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is WUHAN TOPMED TRADING CO. LTD.'s FDA import refusal history?

WUHAN TOPMED TRADING CO. LTD. (FEI: 3022082641) has 1 FDA import refusal record(s) in our database, spanning from 4/25/2022 to 4/25/2022.

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. WUHAN TOPMED TRADING CO. LTD.'s FEI number is 3022082641.

What types of violations has WUHAN TOPMED TRADING CO. LTD. received?

WUHAN TOPMED TRADING CO. LTD. 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 WUHAN TOPMED TRADING CO. LTD. come from?

All FDA import refusal data for WUHAN TOPMED 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.