ImportRefusal LogoImportRefusal

Shantou Chaonan Taimei Industry Co., Ltd.

✅ Low Risk

FEI: 3006671641 • Shantou City, Guangdong • CHINA

FEI

FEI Number

3006671641

📍

Location

Shantou City, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Dongmen, Xiangang, Simapu, Chaonan District, Shantou City, Guangdong, China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/4/2008
Latest Refusal
3/4/2008
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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).

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).

Refusal History

DateProductViolationsDivision
3/4/2008
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Shantou Chaonan Taimei Industry Co., Ltd.'s FDA import refusal history?

Shantou Chaonan Taimei Industry Co., Ltd. (FEI: 3006671641) has 1 FDA import refusal record(s) in our database, spanning from 3/4/2008 to 3/4/2008.

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. Shantou Chaonan Taimei Industry Co., Ltd.'s FEI number is 3006671641.

What types of violations has Shantou Chaonan Taimei Industry Co., Ltd. received?

Shantou Chaonan Taimei Industry Co., Ltd. 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 Shantou Chaonan Taimei Industry Co., Ltd. come from?

All FDA import refusal data for Shantou Chaonan Taimei Industry Co., 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.