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Shina Corporation

⚠️ Moderate Risk

FEI: 3002808190 • Gongju-Si, Chungcheonbnamdo • SOUTH KOREA

FEI

FEI Number

3002808190

📍

Location

Gongju-Si, Chungcheonbnamdo

🇰🇷
🏢

Address

691-1 Boheong-Ri, Useong-Myeon, Gongju-Si, Chungcheonbnamdo, South Korea

Moderate Risk

FDA Import Risk Assessment

39.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
11/3/2016
Latest Refusal
11/3/2016
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

27804×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
11/3/2016
80FMINEEDLE, HYPODERMIC, SINGLE LUMEN
2780DEVICEGMPS
Division of Northern Border Imports (DNBI)
11/3/2016
80FMINEEDLE, HYPODERMIC, SINGLE LUMEN
2780DEVICEGMPS
Division of Northern Border Imports (DNBI)
11/3/2016
80FMINEEDLE, HYPODERMIC, SINGLE LUMEN
2780DEVICEGMPS
Division of Northern Border Imports (DNBI)
11/3/2016
80FMINEEDLE, HYPODERMIC, SINGLE LUMEN
2780DEVICEGMPS
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Shina Corporation's FDA import refusal history?

Shina Corporation (FEI: 3002808190) has 4 FDA import refusal record(s) in our database, spanning from 11/3/2016 to 11/3/2016.

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. Shina Corporation's FEI number is 3002808190.

What types of violations has Shina Corporation received?

Shina Corporation 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 Shina Corporation come from?

All FDA import refusal data for Shina Corporation 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.