ImportRefusal LogoImportRefusal

Alpha Kamino Geis Cargo Inc

⚠️ Moderate Risk

FEI: 3005997005 • Osaka, Osaka • JAPAN

FEI

FEI Number

3005997005

📍

Location

Osaka, Osaka

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 8-15, Hirano-Cho; Chuo, Osaka, Osaka, Japan

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/6/2006
Latest Refusal
12/6/2006
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

752×

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
12/6/2006
66VAA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New York District Office (NYK-DO)
12/6/2006
62CCB39METHYLDOPATE HCL (ANTI-HYPERTENSIVE)
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Alpha Kamino Geis Cargo Inc's FDA import refusal history?

Alpha Kamino Geis Cargo Inc (FEI: 3005997005) has 2 FDA import refusal record(s) in our database, spanning from 12/6/2006 to 12/6/2006.

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. Alpha Kamino Geis Cargo Inc's FEI number is 3005997005.

What types of violations has Alpha Kamino Geis Cargo Inc received?

Alpha Kamino Geis Cargo Inc has been cited for 1 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 Alpha Kamino Geis Cargo Inc come from?

All FDA import refusal data for Alpha Kamino Geis Cargo 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.