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Zhengzhou Shengxin

⚠️ Moderate Risk

FEI: 3008830818 • Zhengzhou, Henan • CHINA

FEI

FEI Number

3008830818

📍

Location

Zhengzhou, Henan

🇨🇳

Country

CHINA
🏢

Address

148 Minggong Lu, HEN, Zhengzhou, Henan, China

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
10/26/2011
Latest Refusal
10/26/2011
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1184×

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).

Refusal History

DateProductViolationsDivision
10/26/2011
76OFXGENERAL PURPOSE DENTAL TRAY
118NOT LISTED
Cincinnati District Office (CIN-DO)
10/26/2011
76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL
118NOT LISTED
Cincinnati District Office (CIN-DO)
10/26/2011
76EBZACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION
118NOT LISTED
Cincinnati District Office (CIN-DO)
10/26/2011
76NXZKIT, DENTAL HYGIENE
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Zhengzhou Shengxin's FDA import refusal history?

Zhengzhou Shengxin (FEI: 3008830818) has 4 FDA import refusal record(s) in our database, spanning from 10/26/2011 to 10/26/2011.

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. Zhengzhou Shengxin's FEI number is 3008830818.

What types of violations has Zhengzhou Shengxin received?

Zhengzhou Shengxin 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 Zhengzhou Shengxin come from?

All FDA import refusal data for Zhengzhou Shengxin 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.