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Banner Toothbrush

✅ Low Risk

FEI: 3006516151 • Guang Dong • CHINA

FEI

FEI Number

3006516151

📍

Location

Guang Dong

🇨🇳

Country

CHINA
🏢

Address

Tower C Industrial Dist., Si Ma Puxian, , Guang Dong, , China

Low Risk

FDA Import Risk Assessment

23.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
12/5/2007
Latest Refusal
12/5/2007
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

32604×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

3414×

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
12/5/2007
76EFWTOOTHBRUSH, MANUAL
3260NO ENGLISH
341REGISTERED
Seattle District Office (SEA-DO)
12/5/2007
76EFWTOOTHBRUSH, MANUAL
3260NO ENGLISH
341REGISTERED
Seattle District Office (SEA-DO)
12/5/2007
76EFWTOOTHBRUSH, MANUAL
3260NO ENGLISH
341REGISTERED
Seattle District Office (SEA-DO)
12/5/2007
76EFWTOOTHBRUSH, MANUAL
3260NO ENGLISH
341REGISTERED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Banner Toothbrush's FDA import refusal history?

Banner Toothbrush (FEI: 3006516151) has 4 FDA import refusal record(s) in our database, spanning from 12/5/2007 to 12/5/2007.

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. Banner Toothbrush's FEI number is 3006516151.

What types of violations has Banner Toothbrush received?

Banner Toothbrush 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 Banner Toothbrush come from?

All FDA import refusal data for Banner Toothbrush 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.