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Zhejiang Tide Optical Co., Ltd.

✅ Low Risk

FEI: 3002969932 • Wenzhou Zhejiang, Zhejiang • CHINA

FEI

FEI Number

3002969932

📍

Location

Wenzhou Zhejiang, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Wenzhou Ouhai Economic, Development Zone, Wenzhou Zhejiang, Zhejiang, China

Low Risk

FDA Import Risk Assessment

23.7
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
5/18/2009
Latest Refusal
8/6/2004
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.2×10%
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
5/18/2009
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
341REGISTERED
Seattle District Office (SEA-DO)
8/6/2004
86HQZFRAME, SPECTACLE
235NOT IMPACT
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Zhejiang Tide Optical Co., Ltd.'s FDA import refusal history?

Zhejiang Tide Optical Co., Ltd. (FEI: 3002969932) has 2 FDA import refusal record(s) in our database, spanning from 8/6/2004 to 5/18/2009.

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. Zhejiang Tide Optical Co., Ltd.'s FEI number is 3002969932.

What types of violations has Zhejiang Tide Optical Co., Ltd. received?

Zhejiang Tide 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 Zhejiang Tide Optical Co., Ltd. come from?

All FDA import refusal data for Zhejiang Tide 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.