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NURISCIENCE INC

⚠️ Moderate Risk

FEI: 3025333924 • Gyeonggi Do • SOUTH KOREA

FEI

FEI Number

3025333924

📍

Location

Gyeonggi Do

🇰🇷
🏢

Address

947 Hanam Daero, , Gyeonggi Do, , South Korea

Moderate Risk

FDA Import Risk Assessment

33.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
2/8/2023
Latest Refusal
2/8/2023
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
27.5×20%
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.

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
2/8/2023
66YJY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
3280FRNMFGREG
72NEW VET DR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NURISCIENCE INC's FDA import refusal history?

NURISCIENCE INC (FEI: 3025333924) has 1 FDA import refusal record(s) in our database, spanning from 2/8/2023 to 2/8/2023.

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. NURISCIENCE INC's FEI number is 3025333924.

What types of violations has NURISCIENCE INC received?

NURISCIENCE INC has been cited for 3 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 NURISCIENCE INC come from?

All FDA import refusal data for NURISCIENCE INC 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.