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Zhejiang Xinchang Hongxin Ent Co

⚠️ Moderate Risk

FEI: 3008801178 • Shaoxing, Zhejiang • CHINA

FEI

FEI Number

3008801178

📍

Location

Shaoxing, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

248 Xinchaixincun, Xinchangxian, Shaoxing, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
8/2/2011
Latest Refusal
8/2/2011
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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.

Refusal History

DateProductViolationsDivision
8/2/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Seattle District Office (SEA-DO)
8/2/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Seattle District Office (SEA-DO)
8/2/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Zhejiang Xinchang Hongxin Ent Co's FDA import refusal history?

Zhejiang Xinchang Hongxin Ent Co (FEI: 3008801178) has 3 FDA import refusal record(s) in our database, spanning from 8/2/2011 to 8/2/2011.

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. Zhejiang Xinchang Hongxin Ent Co's FEI number is 3008801178.

What types of violations has Zhejiang Xinchang Hongxin Ent Co received?

Zhejiang Xinchang Hongxin Ent Co 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 Zhejiang Xinchang Hongxin Ent Co come from?

All FDA import refusal data for Zhejiang Xinchang Hongxin Ent 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.