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Wicked Lasers

⚠️ Moderate Risk

FEI: 3009198495 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3009198495

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

Room 202, NO 82 Hongqiaoxincun, Shanghai, Shanghai, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/21/2011
Latest Refusal
11/21/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
11/21/2011
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Wicked Lasers's FDA import refusal history?

Wicked Lasers (FEI: 3009198495) has 1 FDA import refusal record(s) in our database, spanning from 11/21/2011 to 11/21/2011.

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. Wicked Lasers's FEI number is 3009198495.

What types of violations has Wicked Lasers received?

Wicked Lasers 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 Wicked Lasers come from?

All FDA import refusal data for Wicked Lasers 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.