ImportRefusal LogoImportRefusal

Noevir Co., Ltd.

⚠️ Moderate Risk

FEI: 1000268518 • Kobe, Hyogo • JAPAN

FEI

FEI Number

1000268518

📍

Location

Kobe, Hyogo

🇯🇵

Country

JAPAN
🏢

Address

(Kabu) Noebia, 6 Chome; Minatojimanaka-Machi; Chuo, Kobe, Hyogo, Japan

Moderate Risk

FDA Import Risk Assessment

46.1
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
1/3/2006
Latest Refusal
7/24/2002
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
14.5×10%
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

3104×

POISONOUS

The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.

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).

Refusal History

DateProductViolationsDivision
1/3/2006
60APY99ABRASIVE N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
7/24/2002
53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
310POISONOUS
Los Angeles District Office (LOS-DO)
7/24/2002
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
310POISONOUS
Los Angeles District Office (LOS-DO)
7/24/2002
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
310POISONOUS
Los Angeles District Office (LOS-DO)
7/24/2002
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
310POISONOUS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

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

Noevir Co., Ltd. (FEI: 1000268518) has 5 FDA import refusal record(s) in our database, spanning from 7/24/2002 to 1/3/2006.

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. Noevir Co., Ltd.'s FEI number is 1000268518.

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

Noevir 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 Noevir Co., Ltd. come from?

All FDA import refusal data for Noevir 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.