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Biao Jie Optical Factory

⚠️ Moderate Risk

FEI: 3012101890 • Guangdong • CHINA

FEI

FEI Number

3012101890

📍

Location

Guangdong

🇨🇳

Country

CHINA
🏢

Address

Opp. Of Housing Committeekengzi, , Guangdong, , China

Moderate Risk

FDA Import Risk Assessment

27.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
4/21/2016
Latest Refusal
4/21/2016
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2353×

NOT IMPACT

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

3413×

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

DateProductViolationsDivision
4/21/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Division of Southeast Imports (DSEI)
4/21/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Division of Southeast Imports (DSEI)
4/21/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Biao Jie Optical Factory's FDA import refusal history?

Biao Jie Optical Factory (FEI: 3012101890) has 3 FDA import refusal record(s) in our database, spanning from 4/21/2016 to 4/21/2016.

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. Biao Jie Optical Factory's FEI number is 3012101890.

What types of violations has Biao Jie Optical Factory received?

Biao Jie Optical Factory 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 Biao Jie Optical Factory come from?

All FDA import refusal data for Biao Jie Optical Factory 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.