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Hobei Qianjiang King Phar Medica

✅ Low Risk

FEI: 3004180893 • Qianjiang • CHINA

FEI

FEI Number

3004180893

📍

Location

Qianjiang

🇨🇳

Country

CHINA
🏢

Address

272 Hong Jun Rd, , Qianjiang, , China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/26/2003
Latest Refusal
11/26/2003
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
11/26/2003
80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG)
118NOT LISTED
341REGISTERED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Hobei Qianjiang King Phar Medica's FDA import refusal history?

Hobei Qianjiang King Phar Medica (FEI: 3004180893) has 1 FDA import refusal record(s) in our database, spanning from 11/26/2003 to 11/26/2003.

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. Hobei Qianjiang King Phar Medica's FEI number is 3004180893.

What types of violations has Hobei Qianjiang King Phar Medica received?

Hobei Qianjiang King Phar Medica 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 Hobei Qianjiang King Phar Medica come from?

All FDA import refusal data for Hobei Qianjiang King Phar Medica 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.