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Nanotechbio Co.,Ltd.

⚠️ Moderate Risk

FEI: 2000004005 • Paju City, Gyeonggido • SOUTH KOREA

FEI

FEI Number

2000004005

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Location

Paju City, Gyeonggido

🇰🇷
🏢

Address

100-96 Janggok-Ri,Jori-Eub, , Paju City, Gyeonggido, South Korea

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/22/2006
Latest Refusal
1/19/2006
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

22001×

DIET INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
8/22/2006
66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
1/19/2006
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2200DIET INGRE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Nanotechbio Co.,Ltd.'s FDA import refusal history?

Nanotechbio Co.,Ltd. (FEI: 2000004005) has 2 FDA import refusal record(s) in our database, spanning from 1/19/2006 to 8/22/2006.

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. Nanotechbio Co.,Ltd.'s FEI number is 2000004005.

What types of violations has Nanotechbio Co.,Ltd. received?

Nanotechbio 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 Nanotechbio Co.,Ltd. come from?

All FDA import refusal data for Nanotechbio 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.