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BECTON DICKINSON KOREA

✅ Low Risk

FEI: 3013831618 • Seoul • SOUTH KOREA

FEI

FEI Number

3013831618

📍

Location

Seoul

🇰🇷
🏢

Address

64 4 Nonhyeon-Ro, Gil Gangnam-Gu, Seoul, , South Korea

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/27/2017
Latest Refusal
9/27/2017
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
9/27/2017
80FMINEEDLE, HYPODERMIC, SINGLE LUMEN
118NOT LISTED
3280FRNMFGREG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is BECTON DICKINSON KOREA's FDA import refusal history?

BECTON DICKINSON KOREA (FEI: 3013831618) has 1 FDA import refusal record(s) in our database, spanning from 9/27/2017 to 9/27/2017.

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. BECTON DICKINSON KOREA's FEI number is 3013831618.

What types of violations has BECTON DICKINSON KOREA received?

BECTON DICKINSON KOREA has been cited for 2 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 BECTON DICKINSON KOREA come from?

All FDA import refusal data for BECTON DICKINSON KOREA 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.