ImportRefusal LogoImportRefusal

Shantou City Jin Sia District

✅ Low Risk

FEI: 3004570905 • Guangdong • CHINA

FEI

FEI Number

3004570905

📍

Location

Guangdong

🇨🇳

Country

CHINA
🏢

Address

., , 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
8/24/2011
Latest Refusal
8/24/2011
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).

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
8/24/2011
66VIJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Shantou City Jin Sia District's FDA import refusal history?

Shantou City Jin Sia District (FEI: 3004570905) has 1 FDA import refusal record(s) in our database, spanning from 8/24/2011 to 8/24/2011.

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 City Jin Sia District's FEI number is 3004570905.

What types of violations has Shantou City Jin Sia District received?

Shantou City Jin Sia District 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 City Jin Sia District come from?

All FDA import refusal data for Shantou City Jin Sia District 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.