ImportRefusal LogoImportRefusal

Dong Guan Song Lin Ju Ltd

✅ Low Risk

FEI: 3005493695 • Dong Guan • CHINA

FEI

FEI Number

3005493695

📍

Location

Dong Guan

🇨🇳

Country

CHINA
🏢

Address

Rm 123, Foreign Trade Bldgwengjing Rd,, , Dong Guan, , China

Low Risk

FDA Import Risk Assessment

23.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
2/24/2006
Latest Refusal
2/24/2006
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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).

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
2/24/2006
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
471CSTIC LBLG
Seattle District Office (SEA-DO)
2/24/2006
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Dong Guan Song Lin Ju Ltd's FDA import refusal history?

Dong Guan Song Lin Ju Ltd (FEI: 3005493695) has 2 FDA import refusal record(s) in our database, spanning from 2/24/2006 to 2/24/2006.

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. Dong Guan Song Lin Ju Ltd's FEI number is 3005493695.

What types of violations has Dong Guan Song Lin Ju Ltd received?

Dong Guan Song Lin Ju Ltd has been cited for 3 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 Dong Guan Song Lin Ju Ltd come from?

All FDA import refusal data for Dong Guan Song Lin Ju 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.