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Dots Eyewear Inc.

⚠️ Moderate Risk

FEI: 3004133240 • Tainan City • TAIWAN

FEI

FEI Number

3004133240

📍

Location

Tainan City

🇹🇼

Country

TAIWAN
🏢

Address

No. 120 Zhongzheng 2nd St., Yongkang Dist., Tainan City, , Taiwan

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

5
Total Refusals
2
Unique Violations
3/23/2021
Latest Refusal
5/20/2016
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
10.3×10%
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

2354×

NOT IMPACT

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

2312×

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
3/23/2021
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
Division of Southeast Imports (DSEI)
8/10/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
235NOT IMPACT
Division of West Coast Imports (DWCI)
4/20/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Division of Southeast Imports (DSEI)
4/17/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Division of Southeast Imports (DSEI)
5/20/2016
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Dots Eyewear Inc.'s FDA import refusal history?

Dots Eyewear Inc. (FEI: 3004133240) has 5 FDA import refusal record(s) in our database, spanning from 5/20/2016 to 3/23/2021.

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. Dots Eyewear Inc.'s FEI number is 3004133240.

What types of violations has Dots Eyewear Inc. received?

Dots Eyewear Inc. 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 Dots Eyewear Inc. come from?

All FDA import refusal data for Dots Eyewear Inc. 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.