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WINNER MEDICAL (HUANGGANG) CO., LTD.

⚠️ Moderate Risk

FEI: 3007966889 • Huanggang, Hubei • CHINA

FEI

FEI Number

3007966889

📍

Location

Huanggang, Hubei

🇨🇳

Country

CHINA
🏢

Address

Winner Industrial Park, Chibi Dadao; Huangzhou, Huanggang, Hubei, 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
10/28/2021
Latest Refusal
10/28/2021
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
11.2×30%
Recency
1.9×20%
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

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

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
10/28/2021
80FXXMASK, SURGICAL
223FALSE
508NO 510(K)
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is WINNER MEDICAL (HUANGGANG) CO., LTD.'s FDA import refusal history?

WINNER MEDICAL (HUANGGANG) CO., LTD. (FEI: 3007966889) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2021 to 10/28/2021.

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. WINNER MEDICAL (HUANGGANG) CO., LTD.'s FEI number is 3007966889.

What types of violations has WINNER MEDICAL (HUANGGANG) CO., LTD. received?

WINNER MEDICAL (HUANGGANG) 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 WINNER MEDICAL (HUANGGANG) CO., LTD. come from?

All FDA import refusal data for WINNER MEDICAL (HUANGGANG) 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.