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MANDARIN OPTICAL MANUFACTORY

⚠️ Moderate Risk

FEI: 3013190479 • Bao an County Shenzhe • CHINA

FEI

FEI Number

3013190479

📍

Location

Bao an County Shenzhe

🇨🇳

Country

CHINA
🏢

Address

Tin Liu Village Guang M, , Bao an County Shenzhe, , China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/7/2017
Latest Refusal
11/7/2017
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
11/7/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is MANDARIN OPTICAL MANUFACTORY's FDA import refusal history?

MANDARIN OPTICAL MANUFACTORY (FEI: 3013190479) has 1 FDA import refusal record(s) in our database, spanning from 11/7/2017 to 11/7/2017.

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. MANDARIN OPTICAL MANUFACTORY's FEI number is 3013190479.

What types of violations has MANDARIN OPTICAL MANUFACTORY received?

MANDARIN OPTICAL MANUFACTORY has been cited for 1 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 MANDARIN OPTICAL MANUFACTORY come from?

All FDA import refusal data for MANDARIN OPTICAL MANUFACTORY 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.