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Nano Line Laser Inc

⚠️ Moderate Risk

FEI: 3010988669 • Saint-laurent, QC • CANADA

FEI

FEI Number

3010988669

📍

Location

Saint-laurent, QC

🇨🇦

Country

CANADA
🏢

Address

3612 Boul Poirier, , Saint-laurent, QC, Canada

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/16/2015
Latest Refusal
1/16/2015
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

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
1/16/2015
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
126FAILS STD
47NON STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Nano Line Laser Inc's FDA import refusal history?

Nano Line Laser Inc (FEI: 3010988669) has 1 FDA import refusal record(s) in our database, spanning from 1/16/2015 to 1/16/2015.

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. Nano Line Laser Inc's FEI number is 3010988669.

What types of violations has Nano Line Laser Inc received?

Nano Line Laser 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 Nano Line Laser Inc come from?

All FDA import refusal data for Nano Line Laser 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.