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Pucheng Mincheng Optics Glasses Co

⚠️ Moderate Risk

FEI: 3006747035 • Pucheng • CHINA

FEI

FEI Number

3006747035

📍

Location

Pucheng

🇨🇳

Country

CHINA
🏢

Address

Nanpu Ecological Industrial Park, , Pucheng, , China

Moderate Risk

FDA Import Risk Assessment

29.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
3/1/2013
Latest Refusal
3/1/2013
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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).

2352×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
3/1/2013
86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT
118NOT LISTED
235NOT IMPACT
New Orleans District Office (NOL-DO)
3/1/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pucheng Mincheng Optics Glasses Co's FDA import refusal history?

Pucheng Mincheng Optics Glasses Co (FEI: 3006747035) has 2 FDA import refusal record(s) in our database, spanning from 3/1/2013 to 3/1/2013.

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. Pucheng Mincheng Optics Glasses Co's FEI number is 3006747035.

What types of violations has Pucheng Mincheng Optics Glasses Co received?

Pucheng Mincheng Optics Glasses Co 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 Pucheng Mincheng Optics Glasses Co come from?

All FDA import refusal data for Pucheng Mincheng Optics Glasses 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.