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NINGBO SIDER GLASSES CO., LTD

⚠️ Moderate Risk

FEI: 3030550173 • Zhejiang • CHINA

FEI

FEI Number

3030550173

📍

Location

Zhejiang

🇨🇳

Country

CHINA
🏢

Address

No.128 Huisheng Rd,Feng, , Zhejiang, , China

Moderate Risk

FDA Import Risk Assessment

38.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
4/11/2024
Latest Refusal
4/11/2024
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
11.2×30%
Recency
64.5×20%
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).

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

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
4/11/2024
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NINGBO SIDER GLASSES CO., LTD's FDA import refusal history?

NINGBO SIDER GLASSES CO., LTD (FEI: 3030550173) has 1 FDA import refusal record(s) in our database, spanning from 4/11/2024 to 4/11/2024.

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 SIDER GLASSES CO., LTD's FEI number is 3030550173.

What types of violations has NINGBO SIDER GLASSES CO., LTD received?

NINGBO SIDER GLASSES CO., 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 NINGBO SIDER GLASSES CO., LTD come from?

All FDA import refusal data for NINGBO SIDER GLASSES 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.