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Heilongjiang Beidahuang Fengrui Biotechnology Co Ltd

⚠️ Moderate Risk

FEI: 3008481313 • Haerbinshi, Heilongjiangsheng • CHINA

FEI

FEI Number

3008481313

📍

Location

Haerbinshi, Heilongjiangsheng

🇨🇳

Country

CHINA
🏢

Address

9 Hapingxilu, Harbin Development Zone, Haerbinshi, Heilongjiangsheng, China

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
3/3/2010
Latest Refusal
3/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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).

Refusal History

DateProductViolationsDivision
3/3/2010
61LCS08HEPARIN SODIUM (ANTI-COAGULANT)
118NOT LISTED
Chicago District Office (CHI-DO)
3/3/2010
61LSC08HEPARIN SODIUM (ANTI-COAGULANT)
118NOT LISTED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Heilongjiang Beidahuang Fengrui Biotechnology Co Ltd's FDA import refusal history?

Heilongjiang Beidahuang Fengrui Biotechnology Co Ltd (FEI: 3008481313) has 2 FDA import refusal record(s) in our database, spanning from 3/3/2010 to 3/3/2010.

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. Heilongjiang Beidahuang Fengrui Biotechnology Co Ltd's FEI number is 3008481313.

What types of violations has Heilongjiang Beidahuang Fengrui Biotechnology Co Ltd received?

Heilongjiang Beidahuang Fengrui Biotechnology 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 Heilongjiang Beidahuang Fengrui Biotechnology Co Ltd come from?

All FDA import refusal data for Heilongjiang Beidahuang Fengrui Biotechnology 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.