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Beijing Cosmelights Technology Co Ltd

⚠️ Moderate Risk

FEI: 3010932745 • Beijingshi, Beijingshi • CHINA

FEI

FEI Number

3010932745

📍

Location

Beijingshi, Beijingshi

🇨🇳

Country

CHINA
🏢

Address

Room 2705 1 Xinghualu, , Beijingshi, Beijingshi, China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
8/21/2014
Latest Refusal
8/21/2014
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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
8/21/2014
79GEXPOWERED LASER SURGICAL INSTRUMENTS
118NOT LISTED
16DIRECTIONS
476NO REGISTR
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Beijing Cosmelights Technology Co Ltd's FDA import refusal history?

Beijing Cosmelights Technology Co Ltd (FEI: 3010932745) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2014 to 8/21/2014.

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. Beijing Cosmelights Technology Co Ltd's FEI number is 3010932745.

What types of violations has Beijing Cosmelights Technology Co Ltd received?

Beijing Cosmelights 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 Beijing Cosmelights Technology Co Ltd come from?

All FDA import refusal data for Beijing Cosmelights 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.