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DANYANG SAN-SINO OPTICAL CO., LTD.

⚠️ Moderate Risk

FEI: 3006750739 • Zhenjiangshi, Jiangsusheng • CHINA

FEI

FEI Number

3006750739

📍

Location

Zhenjiangshi, Jiangsusheng

🇨🇳

Country

CHINA
🏢

Address

GLASSES INDUSTRIAL PARK, , Zhenjiangshi, Jiangsusheng, 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
2
Unique Violations
2/26/2009
Latest Refusal
12/24/2008
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

2352×

NOT IMPACT

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

2311×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

Refusal History

DateProductViolationsDivision
2/26/2009
86HQZFRAME, SPECTACLE
231LENS CERT
Cincinnati District Office (CIN-DO)
1/29/2009
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
Seattle District Office (SEA-DO)
12/24/2008
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is DANYANG SAN-SINO OPTICAL CO., LTD.'s FDA import refusal history?

DANYANG SAN-SINO OPTICAL CO., LTD. (FEI: 3006750739) has 3 FDA import refusal record(s) in our database, spanning from 12/24/2008 to 2/26/2009.

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 SAN-SINO OPTICAL CO., LTD.'s FEI number is 3006750739.

What types of violations has DANYANG SAN-SINO OPTICAL CO., LTD. received?

DANYANG SAN-SINO OPTICAL CO., LTD. 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 DANYANG SAN-SINO OPTICAL CO., LTD. come from?

All FDA import refusal data for DANYANG SAN-SINO OPTICAL CO., LTD. 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.