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NINGBO WEIFENG HOUSEWARE CO

⚠️ Moderate Risk

FEI: 3013791238 • Wangchun District • CHINA

FEI

FEI Number

3013791238

📍

Location

Wangchun District

🇨🇳

Country

CHINA
🏢

Address

No.128, Buzheng East Ro, , Wangchun District, , China

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
10/19/2017
Latest Refusal
10/19/2017
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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).

2311×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

32801×

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.

Refusal History

DateProductViolationsDivision
10/19/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
231LENS CERT
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NINGBO WEIFENG HOUSEWARE CO's FDA import refusal history?

NINGBO WEIFENG HOUSEWARE CO (FEI: 3013791238) has 1 FDA import refusal record(s) in our database, spanning from 10/19/2017 to 10/19/2017.

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. NINGBO WEIFENG HOUSEWARE CO's FEI number is 3013791238.

What types of violations has NINGBO WEIFENG HOUSEWARE CO received?

NINGBO WEIFENG HOUSEWARE CO 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 NINGBO WEIFENG HOUSEWARE CO come from?

All FDA import refusal data for NINGBO WEIFENG HOUSEWARE CO 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.