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Hongfeng Intl Co.,

✅ Low Risk

FEI: 3010128697 • Shanghai • CHINA

FEI

FEI Number

3010128697

📍

Location

Shanghai

🇨🇳

Country

CHINA
🏢

Address

108 Huang Bang Rd, , Shanghai, , China

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
10/2/2013
Latest Refusal
10/2/2013
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

DateProductViolationsDivision
10/2/2013
87HXBPROBE
118NOT LISTED
16DIRECTIONS
333LACKS FIRM
335LACKS N/C
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Hongfeng Intl Co.,'s FDA import refusal history?

Hongfeng Intl Co., (FEI: 3010128697) has 1 FDA import refusal record(s) in our database, spanning from 10/2/2013 to 10/2/2013.

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. Hongfeng Intl Co.,'s FEI number is 3010128697.

What types of violations has Hongfeng Intl Co., received?

Hongfeng Intl Co., has been cited for 4 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 Hongfeng Intl Co., come from?

All FDA import refusal data for Hongfeng Intl Co., 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.