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Beijing Lei Li Zi

⚠️ Moderate Risk

FEI: 3011692587 • Beijing • CHINA

FEI

FEI Number

3011692587

📍

Location

Beijing

🇨🇳

Country

CHINA
🏢

Address

Jiu Xian Qiao Rd, , Beijing, , China

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
9/16/2015
Latest Refusal
9/16/2015
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

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
9/16/2015
79GEXPOWERED LASER SURGICAL INSTRUMENTS
118NOT LISTED
3280FRNMFGREG
476NO REGISTR
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Beijing Lei Li Zi's FDA import refusal history?

Beijing Lei Li Zi (FEI: 3011692587) has 1 FDA import refusal record(s) in our database, spanning from 9/16/2015 to 9/16/2015.

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. Beijing Lei Li Zi's FEI number is 3011692587.

What types of violations has Beijing Lei Li Zi received?

Beijing Lei Li Zi 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 Lei Li Zi come from?

All FDA import refusal data for Beijing Lei Li Zi 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.