ImportRefusal LogoImportRefusal

NIPRO MEDICAL INDUSTRIES CO., LTD

✅ Low Risk

FEI: 3013732683 • Seoul • SOUTH KOREA

FEI

FEI Number

3013732683

📍

Location

Seoul

🇰🇷
🏢

Address

Jongro-Gu, 5 Th Flr, 4, 12-Gil, Daehak-Ro, Seoul, , South Korea

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
9/18/2017
Latest Refusal
9/18/2017
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

Refusal History

DateProductViolationsDivision
9/18/2017
80FMINEEDLE, HYPODERMIC, SINGLE LUMEN
3260NO ENGLISH
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NIPRO MEDICAL INDUSTRIES CO., LTD's FDA import refusal history?

NIPRO MEDICAL INDUSTRIES CO., LTD (FEI: 3013732683) has 1 FDA import refusal record(s) in our database, spanning from 9/18/2017 to 9/18/2017.

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. NIPRO MEDICAL INDUSTRIES CO., LTD's FEI number is 3013732683.

What types of violations has NIPRO MEDICAL INDUSTRIES CO., LTD received?

NIPRO MEDICAL INDUSTRIES 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 NIPRO MEDICAL INDUSTRIES CO., LTD come from?

All FDA import refusal data for NIPRO MEDICAL INDUSTRIES 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.