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Harbin Pharmaceutical Group Co Ltd

✅ Low Risk

FEI: 3003538250 • Harbin • CHINA

FEI

FEI Number

3003538250

📍

Location

Harbin

🇨🇳

Country

CHINA
🏢

Address

431 Youyi Road Daoli Dist., , Harbin, , China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
5/3/2002
Latest Refusal
5/3/2002
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

Refusal History

DateProductViolationsDivision
5/3/2002
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Harbin Pharmaceutical Group Co Ltd's FDA import refusal history?

Harbin Pharmaceutical Group Co Ltd (FEI: 3003538250) has 1 FDA import refusal record(s) in our database, spanning from 5/3/2002 to 5/3/2002.

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. Harbin Pharmaceutical Group Co Ltd's FEI number is 3003538250.

What types of violations has Harbin Pharmaceutical Group Co Ltd received?

Harbin Pharmaceutical Group 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 Harbin Pharmaceutical Group Co Ltd come from?

All FDA import refusal data for Harbin Pharmaceutical Group 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.