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WU HAN HAI NA CUAN SCIENCE AND T

✅ Low Risk

FEI: 3014300409 • Wuhan • CHINA

FEI

FEI Number

3014300409

📍

Location

Wuhan

🇨🇳

Country

CHINA
🏢

Address

# 3f, 7 Guan Nan Fu Xing, Wuhan, , China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
6/1/2018
Latest Refusal
6/1/2018
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

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
6/1/2018
80OUGMEDICAL DEVICE DATA SYSTEM
118NOT LISTED
3260NO ENGLISH
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is WU HAN HAI NA CUAN SCIENCE AND T's FDA import refusal history?

WU HAN HAI NA CUAN SCIENCE AND T (FEI: 3014300409) has 1 FDA import refusal record(s) in our database, spanning from 6/1/2018 to 6/1/2018.

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. WU HAN HAI NA CUAN SCIENCE AND T's FEI number is 3014300409.

What types of violations has WU HAN HAI NA CUAN SCIENCE AND T received?

WU HAN HAI NA CUAN SCIENCE AND T 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 WU HAN HAI NA CUAN SCIENCE AND T come from?

All FDA import refusal data for WU HAN HAI NA CUAN SCIENCE AND T 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.