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Shouying Industrial Shenzhen Co Ltd

⚠️ Moderate Risk

FEI: 3004564322 • Shenzhen • CHINA

FEI

FEI Number

3004564322

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

Hebie Industry Area, Shuoying Road; Longhua Town, Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
12/28/2009
Latest Refusal
12/28/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
12/28/2009
66BCQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Shouying Industrial Shenzhen Co Ltd's FDA import refusal history?

Shouying Industrial Shenzhen Co Ltd (FEI: 3004564322) has 1 FDA import refusal record(s) in our database, spanning from 12/28/2009 to 12/28/2009.

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. Shouying Industrial Shenzhen Co Ltd's FEI number is 3004564322.

What types of violations has Shouying Industrial Shenzhen Co Ltd received?

Shouying Industrial Shenzhen Co Ltd has been cited for 1 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 Shouying Industrial Shenzhen Co Ltd come from?

All FDA import refusal data for Shouying Industrial Shenzhen 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.