NIZONA CORPORATION

⚠️ Moderate Risk

FEI: 3012936874 • Kobe, Hyogo • JAPAN

FEI

FEI Number

3012936874

📍

Location

Kobe, Hyogo

🇯🇵

Country

JAPAN

🏢

Address

Sannomiya Venture B, Hamabe Dori 4-1-23, Chuo-Ku, Kobe, Hyogo, Japan

Moderate Risk

FDA Import Risk Assessment

38.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/13/2017

Latest Refusal

2/13/2017

Earliest Refusal

Score Breakdown

Violation Severity

54.3×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

70.0×10%

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

Violation Summary

4827×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

2384×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

23003×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

Refusal History

Date	Product	Violations	Division
2/13/2017	54CCT99PROTEIN N.E.C.	2300DIETARYLBL 482NUTRIT LBL	Division of West Coast Imports (DWCI)
2/13/2017	54CCT99PROTEIN N.E.C.	2300DIETARYLBL 482NUTRIT LBL	Division of West Coast Imports (DWCI)
2/13/2017	54CCT99PROTEIN N.E.C.	2300DIETARYLBL 482NUTRIT LBL	Division of West Coast Imports (DWCI)
2/13/2017	54CCT99PROTEIN N.E.C.	238UNSAFE ADD 482NUTRIT LBL	Division of West Coast Imports (DWCI)
2/13/2017	54CCT99PROTEIN N.E.C.	238UNSAFE ADD 482NUTRIT LBL	Division of West Coast Imports (DWCI)
2/13/2017	54CCT99PROTEIN N.E.C.	238UNSAFE ADD 482NUTRIT LBL	Division of West Coast Imports (DWCI)
2/13/2017	54CCT99PROTEIN N.E.C.	238UNSAFE ADD 482NUTRIT LBL	Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is NIZONA CORPORATION's FDA import refusal history?

NIZONA CORPORATION (FEI: 3012936874) has 7 FDA import refusal record(s) in our database, spanning from 2/13/2017 to 2/13/2017.

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. NIZONA CORPORATION's FEI number is 3012936874.

What types of violations has NIZONA CORPORATION received?

NIZONA CORPORATION 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 NIZONA CORPORATION come from?

All FDA import refusal data for NIZONA CORPORATION 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.