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DANYANG NEW HORIZON GLASSES MANUFA

✅ Low Risk

FEI: 3015915434 • Zhen Jiang, Jiangsu • CHINA

FEI

FEI Number

3015915434

📍

Location

Zhen Jiang, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

(Spb)(N3p)Xuejia Xu Jiatiao, Situ Tn; Yunyangzhen Danyang, Zhen Jiang, Jiangsu, China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/21/2020
Latest Refusal
10/21/2020
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
10/21/2020
86HQZFRAME, SPECTACLE
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is DANYANG NEW HORIZON GLASSES MANUFA's FDA import refusal history?

DANYANG NEW HORIZON GLASSES MANUFA (FEI: 3015915434) has 1 FDA import refusal record(s) in our database, spanning from 10/21/2020 to 10/21/2020.

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. DANYANG NEW HORIZON GLASSES MANUFA's FEI number is 3015915434.

What types of violations has DANYANG NEW HORIZON GLASSES MANUFA received?

DANYANG NEW HORIZON GLASSES MANUFA 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 DANYANG NEW HORIZON GLASSES MANUFA come from?

All FDA import refusal data for DANYANG NEW HORIZON GLASSES MANUFA 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.