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SHENZHEN HONGFU INTERNATIONAL CO

Low Risk

FEI: 3020679822 • Shenzhen • CHINA

FEI

FEI Number

3020679822

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

Modern Factory B7 Longtan 3rd, District Tianxin Community, Shenzhen, , China

Low Risk

FDA Import Risk Assessment

23.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/1/2022
Latest Refusal
6/1/2022
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
13.7×20%
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).

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
6/1/2022
56YQF99ANTIBIOTIC N.E.C.
118NOT LISTED
472NO ENGLISH
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is SHENZHEN HONGFU INTERNATIONAL CO's FDA import refusal history?

SHENZHEN HONGFU INTERNATIONAL CO (FEI: 3020679822) has 1 FDA import refusal record(s) in our database, spanning from 6/1/2022 to 6/1/2022.

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. SHENZHEN HONGFU INTERNATIONAL CO's FEI number is 3020679822.

What types of violations has SHENZHEN HONGFU INTERNATIONAL CO received?

SHENZHEN HONGFU INTERNATIONAL CO 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 SHENZHEN HONGFU INTERNATIONAL CO come from?

All FDA import refusal data for SHENZHEN HONGFU INTERNATIONAL 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.