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Zhongshan Zhongnan Optical Co. Ltd.

✅ Low Risk

FEI: 3005395949 • Guangdong • CHINA

FEI

FEI Number

3005395949

📍

Location

Guangdong

🇨🇳

Country

CHINA
🏢

Address

#6 Chang Cheng Bei Lu, Aqancheng District, Zhongshan Shi, Guangdong, , 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
1
Unique Violations
10/27/2005
Latest Refusal
10/27/2005
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
10/27/2005
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
118NOT LISTED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Zhongshan Zhongnan Optical Co. Ltd.'s FDA import refusal history?

Zhongshan Zhongnan Optical Co. Ltd. (FEI: 3005395949) has 1 FDA import refusal record(s) in our database, spanning from 10/27/2005 to 10/27/2005.

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. Zhongshan Zhongnan Optical Co. Ltd.'s FEI number is 3005395949.

What types of violations has Zhongshan Zhongnan Optical Co. Ltd. received?

Zhongshan Zhongnan Optical Co. Ltd. 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 Zhongshan Zhongnan Optical Co. Ltd. come from?

All FDA import refusal data for Zhongshan Zhongnan 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.