ImportRefusal LogoImportRefusal

Big Dipper Laser Science and Technology Co Ltd

⚠️ Moderate Risk

FEI: 3005635669 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3005635669

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Ailian, NO 42 Longtengnanlu; Longgang, Shenzhen, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

31.6
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
5/13/2015
Latest Refusal
10/24/2013
Earliest Refusal

Score Breakdown

Violation Severity
57.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
19.4×10%
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

472×

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.

2781×

NO TAG

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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
5/13/2015
95REBHIGH-POWER LASER LIGHT SHOW, DISPLAY PRODUCTS
278NO TAG
476NO REGISTR
Cincinnati District Office (CIN-DO)
10/24/2013
95REBHIGH-POWER LASER LIGHT SHOW, DISPLAY PRODUCTS
47NON STD
San Francisco District Office (SAN-DO)
10/24/2013
95REBHIGH-POWER LASER LIGHT SHOW, DISPLAY PRODUCTS
47NON STD
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Big Dipper Laser Science and Technology Co Ltd's FDA import refusal history?

Big Dipper Laser Science and Technology Co Ltd (FEI: 3005635669) has 3 FDA import refusal record(s) in our database, spanning from 10/24/2013 to 5/13/2015.

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. Big Dipper Laser Science and Technology Co Ltd's FEI number is 3005635669.

What types of violations has Big Dipper Laser Science and Technology Co Ltd received?

Big Dipper Laser Science and Technology Co Ltd has been cited for 3 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 Big Dipper Laser Science and Technology Co Ltd come from?

All FDA import refusal data for Big Dipper Laser Science and Technology 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.