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Zhang, Bernard

⚠️ Moderate Risk

FEI: 3005788258 • Shanghai • CHINA

FEI

FEI Number

3005788258

📍

Location

Shanghai

🇨🇳

Country

CHINA
🏢

Address

1357 Orient Rd /#11a, , Shanghai, , 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
2
Unique Violations
8/4/2006
Latest Refusal
8/4/2006
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).

3421×

PERSONALRX

The article appears to be a drug which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
8/4/2006
60RCR19SIBUTRAMINE HCL MONOHYDRATE (ANOREXIC)
118NOT LISTED
342PERSONALRX
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Zhang, Bernard's FDA import refusal history?

Zhang, Bernard (FEI: 3005788258) has 1 FDA import refusal record(s) in our database, spanning from 8/4/2006 to 8/4/2006.

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. Zhang, Bernard's FEI number is 3005788258.

What types of violations has Zhang, Bernard received?

Zhang, Bernard 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 Zhang, Bernard come from?

All FDA import refusal data for Zhang, Bernard 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.