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BIOCOSONE CO.,LTD

⚠️ Moderate Risk

FEI: 3019417073 • Dangjin, Chungcheongnam • SOUTH KOREA

FEI

FEI Number

3019417073

📍

Location

Dangjin, Chungcheongnam

🇰🇷
🏢

Address

1 Daehak-Ro, Jeongmi-Myeon, Dangjin, Chungcheongnam, South Korea

Moderate Risk

FDA Import Risk Assessment

28.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/1/2022
Latest Refusal
11/1/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
22.1×20%
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.

Refusal History

DateProductViolationsDivision
11/1/2022
62FBY99ANTI-INFECTIVE, TOPICAL N.E.C.
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BIOCOSONE CO.,LTD's FDA import refusal history?

BIOCOSONE CO.,LTD (FEI: 3019417073) has 1 FDA import refusal record(s) in our database, spanning from 11/1/2022 to 11/1/2022.

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. BIOCOSONE CO.,LTD's FEI number is 3019417073.

What types of violations has BIOCOSONE CO.,LTD received?

BIOCOSONE 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 BIOCOSONE CO.,LTD come from?

All FDA import refusal data for BIOCOSONE 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.