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Beijing Liaison De

⚠️ Moderate Risk

FEI: 3005706310 • Beijing • CHINA

FEI

FEI Number

3005706310

📍

Location

Beijing

🇨🇳

Country

CHINA
🏢

Address

Block 5 Shiji, , Beijing, , China

Moderate Risk

FDA Import Risk Assessment

44.5
LowModerateHighCritical

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

Statistics

11
Total Refusals
2
Unique Violations
6/19/2012
Latest Refusal
10/28/2011
Earliest Refusal

Score Breakdown

Violation Severity
56.3×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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

11811×

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).

5085×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
6/19/2012
76EJSALLOY, PRECIOUS METAL, FOR CLINICAL USE
118NOT LISTED
New Orleans District Office (NOL-DO)
6/19/2012
76NSLDENTURES, FULL
118NOT LISTED
New Orleans District Office (NOL-DO)
6/19/2012
76NSKDENTURES, PARTIAL
118NOT LISTED
New Orleans District Office (NOL-DO)
6/19/2012
76EIHPOWDER, PORCELAIN
118NOT LISTED
New Orleans District Office (NOL-DO)
6/19/2012
76ELZCROWN, PREFORMED
118NOT LISTED
New Orleans District Office (NOL-DO)
6/18/2012
76ELMDENTURE, PLASTIC, TEETH
118NOT LISTED
New Orleans District Office (NOL-DO)
10/28/2011
76NSKDENTURES, PARTIAL
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/28/2011
76NSKDENTURES, PARTIAL
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/28/2011
76ELZCROWN, PREFORMED
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/28/2011
76ELLTEETH, PORCELAIN
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)
10/28/2011
76EHYTRAY, IMPRESSION, PREFORMED
118NOT LISTED
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Beijing Liaison De's FDA import refusal history?

Beijing Liaison De (FEI: 3005706310) has 11 FDA import refusal record(s) in our database, spanning from 10/28/2011 to 6/19/2012.

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. Beijing Liaison De's FEI number is 3005706310.

What types of violations has Beijing Liaison De received?

Beijing Liaison De 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 Beijing Liaison De come from?

All FDA import refusal data for Beijing Liaison De 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.