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Lianyungang Ruidong International Co. Ltd

⚠️ Moderate Risk

FEI: 3008991969 • Lianyungang • CHINA

FEI

FEI Number

3008991969

📍

Location

Lianyungang

🇨🇳

Country

CHINA
🏢

Address

Rmd 11 4/F B No. Longhe Building, , Lianyungang, , China

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/11/2011
Latest Refusal
7/11/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

752×

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
7/11/2011
61HCS03TRIMETHOPRIM (ANTI-BACTERIAL)
75UNAPPROVED
Florida District Office (FLA-DO)
7/11/2011
62OCS28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Lianyungang Ruidong International Co. Ltd's FDA import refusal history?

Lianyungang Ruidong International Co. Ltd (FEI: 3008991969) has 2 FDA import refusal record(s) in our database, spanning from 7/11/2011 to 7/11/2011.

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. Lianyungang Ruidong International Co. Ltd's FEI number is 3008991969.

What types of violations has Lianyungang Ruidong International Co. Ltd received?

Lianyungang Ruidong International 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 Lianyungang Ruidong International Co. Ltd come from?

All FDA import refusal data for Lianyungang Ruidong International 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.