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Xiamen Zhongshi Optical Industry Co., Ltd.

✅ Low Risk

FEI: 3008770700 • Xiamen • CHINA

FEI

FEI Number

3008770700

📍

Location

Xiamen

🇨🇳

Country

CHINA
🏢

Address

Building 153, Tongan Industry Zone, Xiamen, , China

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/14/2013
Latest Refusal
6/14/2013
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

2351×

NOT IMPACT

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

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
6/14/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Xiamen Zhongshi Optical Industry Co., Ltd.'s FDA import refusal history?

Xiamen Zhongshi Optical Industry Co., Ltd. (FEI: 3008770700) has 1 FDA import refusal record(s) in our database, spanning from 6/14/2013 to 6/14/2013.

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. Xiamen Zhongshi Optical Industry Co., Ltd.'s FEI number is 3008770700.

What types of violations has Xiamen Zhongshi Optical Industry Co., Ltd. received?

Xiamen Zhongshi Optical Industry 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 Xiamen Zhongshi Optical Industry Co., Ltd. come from?

All FDA import refusal data for Xiamen Zhongshi Optical Industry 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.