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BAIYUNHUI GROUP

✅ Low Risk

FEI: 3013707505 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3013707505

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Baiyunhui Group Bldg No, , Guangzhou, Guangdong, 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
2
Unique Violations
10/10/2017
Latest Refusal
10/10/2017
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).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
10/10/2017
53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
118NOT LISTED
473LABELING
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BAIYUNHUI GROUP's FDA import refusal history?

BAIYUNHUI GROUP (FEI: 3013707505) has 1 FDA import refusal record(s) in our database, spanning from 10/10/2017 to 10/10/2017.

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. BAIYUNHUI GROUP's FEI number is 3013707505.

What types of violations has BAIYUNHUI GROUP received?

BAIYUNHUI GROUP 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 BAIYUNHUI GROUP come from?

All FDA import refusal data for BAIYUNHUI GROUP 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.