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Y&K BIOCOS CO., LTD.

✅ Low Risk

FEI: 3016107568 • Anseong, Gyeonggi • SOUTH KOREA

FEI

FEI Number

3016107568

📍

Location

Anseong, Gyeonggi

🇰🇷
🏢

Address

40 Je 3gongdan3-Gil, Seoun-Myeon, Anseong, Gyeonggi, South Korea

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/30/2020
Latest Refusal
4/30/2020
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

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.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
4/30/2020
79NACDRESSING, WOUND, HYDROPHILIC
3280FRNMFGREG
341REGISTERED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Y&K BIOCOS CO., LTD.'s FDA import refusal history?

Y&K BIOCOS CO., LTD. (FEI: 3016107568) has 1 FDA import refusal record(s) in our database, spanning from 4/30/2020 to 4/30/2020.

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. Y&K BIOCOS CO., LTD.'s FEI number is 3016107568.

What types of violations has Y&K BIOCOS CO., LTD. received?

Y&K BIOCOS CO., LTD. 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 Y&K BIOCOS CO., LTD. come from?

All FDA import refusal data for Y&K BIOCOS 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.