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GLOBALFIELD INC.

⚠️ Moderate Risk

FEI: 3012397152 • Fujisawa, Kanagawa • JAPAN

FEI

FEI Number

3012397152

📍

Location

Fujisawa, Kanagawa

🇯🇵

Country

JAPAN
🏢

Address

1034-7, Asahi-Cho, Fujisawa, Kanagawa, Japan

Moderate Risk

FDA Import Risk Assessment

31.7
LowModerateHighCritical

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

Statistics

8
Total Refusals
2
Unique Violations
8/2/2016
Latest Refusal
7/26/2016
Earliest Refusal

Score Breakdown

Violation Severity
32.7×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

3248×

NO ENGLISH

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

4823×

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.

Refusal History

DateProductViolationsDivision
8/2/2016
33YYT99CANDY WITHOUT CHOCOLATE N.E.C.
324NO ENGLISH
482NUTRIT LBL
Cincinnati District Office (CIN-DO)
8/2/2016
30YYT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
324NO ENGLISH
482NUTRIT LBL
Cincinnati District Office (CIN-DO)
8/2/2016
07YYT99SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
324NO ENGLISH
482NUTRIT LBL
Cincinnati District Office (CIN-DO)
8/2/2016
31AYT99COFFEE, N.E.C.
324NO ENGLISH
Cincinnati District Office (CIN-DO)
8/2/2016
31KYT02TEA, GREEN
324NO ENGLISH
Cincinnati District Office (CIN-DO)
7/26/2016
31KYT99TEA, N.E.C.
324NO ENGLISH
Cincinnati District Office (CIN-DO)
7/26/2016
30YYT99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
324NO ENGLISH
Cincinnati District Office (CIN-DO)
7/26/2016
07YYT99SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
324NO ENGLISH
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is GLOBALFIELD INC.'s FDA import refusal history?

GLOBALFIELD INC. (FEI: 3012397152) has 8 FDA import refusal record(s) in our database, spanning from 7/26/2016 to 8/2/2016.

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. GLOBALFIELD INC.'s FEI number is 3012397152.

What types of violations has GLOBALFIELD INC. received?

GLOBALFIELD INC. 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 GLOBALFIELD INC. come from?

All FDA import refusal data for GLOBALFIELD 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.