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Nlight Laser Shanghai Co., Ltd

⚠️ Moderate Risk

FEI: 3005753368 • Shanghai • CHINA

FEI

FEI Number

3005753368

📍

Location

Shanghai

🇨🇳

Country

CHINA
🏢

Address

3000 Longdong Avenue Bldg 5,#519, , Shanghai, , China

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/15/2012
Latest Refusal
6/15/2012
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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.

Refusal History

DateProductViolationsDivision
6/15/2012
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
126FAILS STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Nlight Laser Shanghai Co., Ltd's FDA import refusal history?

Nlight Laser Shanghai Co., Ltd (FEI: 3005753368) has 1 FDA import refusal record(s) in our database, spanning from 6/15/2012 to 6/15/2012.

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. Nlight Laser Shanghai Co., Ltd's FEI number is 3005753368.

What types of violations has Nlight Laser Shanghai Co., Ltd received?

Nlight Laser Shanghai Co., Ltd 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 Nlight Laser Shanghai Co., Ltd come from?

All FDA import refusal data for Nlight Laser Shanghai 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.