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AI BEI (ZHEN JIANG) OPTICAL EYEGLAS

✅ Low Risk

FEI: 3015188218 • Jiangsu • CHINA

FEI

FEI Number

3015188218

📍

Location

Jiangsu

🇨🇳

Country

CHINA
🏢

Address

3rd Floor, Hopesun Building, Technology Development District, Jiangsu, , China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
9/11/2019
Latest Refusal
9/11/2019
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

3411×

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
9/11/2019
86HOISPECTACLE, MAGNIFYING
2480RXPERSONAL
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is AI BEI (ZHEN JIANG) OPTICAL EYEGLAS's FDA import refusal history?

AI BEI (ZHEN JIANG) OPTICAL EYEGLAS (FEI: 3015188218) has 1 FDA import refusal record(s) in our database, spanning from 9/11/2019 to 9/11/2019.

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. AI BEI (ZHEN JIANG) OPTICAL EYEGLAS's FEI number is 3015188218.

What types of violations has AI BEI (ZHEN JIANG) OPTICAL EYEGLAS received?

AI BEI (ZHEN JIANG) OPTICAL EYEGLAS 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 AI BEI (ZHEN JIANG) OPTICAL EYEGLAS come from?

All FDA import refusal data for AI BEI (ZHEN JIANG) OPTICAL EYEGLAS 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.