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SUZHOU DIYAO PHOTO ELEC MATERIAL

⚠️ Moderate Risk

FEI: 3014657816 • Suzhou • CHINA

FEI

FEI Number

3014657816

📍

Location

Suzhou

🇨🇳

Country

CHINA
🏢

Address

No. 159 Qinyang Road., , Suzhou, , China

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
11/21/2018
Latest Refusal
11/21/2018
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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).

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
11/21/2018
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SUZHOU DIYAO PHOTO ELEC MATERIAL's FDA import refusal history?

SUZHOU DIYAO PHOTO ELEC MATERIAL (FEI: 3014657816) has 1 FDA import refusal record(s) in our database, spanning from 11/21/2018 to 11/21/2018.

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. SUZHOU DIYAO PHOTO ELEC MATERIAL's FEI number is 3014657816.

What types of violations has SUZHOU DIYAO PHOTO ELEC MATERIAL received?

SUZHOU DIYAO PHOTO ELEC MATERIAL 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 SUZHOU DIYAO PHOTO ELEC MATERIAL come from?

All FDA import refusal data for SUZHOU DIYAO PHOTO ELEC MATERIAL 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.