WINNER SHEEN INTERNATIONAL LTD.

⚠️ Moderate Risk

FEI: 3013284417 • Hangzhou, Zhejiang • CHINA

FEI

FEI Number

3013284417

📍

Location

Hangzhou, Zhejiang

🇨🇳

Country

CHINA

🏢

Address

Yufeng Building, No. 388 Fengtan Road, Hangzhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

32.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

12/6/2019

Latest Refusal

12/6/2019

Earliest Refusal

Score Breakdown

Violation Severity

43.3×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

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

1186×

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).

32806×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

3416×

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).

Refusal History

Date	Product	Violations	Division
12/6/2019	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
12/6/2019	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
12/6/2019	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
12/6/2019	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
12/6/2019	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)
12/6/2019	80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE	118NOT LISTED 3280FRNMFGREG 341REGISTERED	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is WINNER SHEEN INTERNATIONAL LTD.'s FDA import refusal history?

WINNER SHEEN INTERNATIONAL LTD. (FEI: 3013284417) has 6 FDA import refusal record(s) in our database, spanning from 12/6/2019 to 12/6/2019.

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 SHEEN INTERNATIONAL LTD.'s FEI number is 3013284417.

What types of violations has WINNER SHEEN INTERNATIONAL LTD. received?

WINNER SHEEN INTERNATIONAL 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 WINNER SHEEN INTERNATIONAL LTD. come from?

All FDA import refusal data for WINNER SHEEN INTERNATIONAL 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.