ImportRefusal LogoImportRefusal

BOURBON CORPORATION

⚠️ Moderate Risk

FEI: 2000006691 • Niigata, Niigata • JAPAN

FEI

FEI Number

2000006691

📍

Location

Niigata, Niigata

🇯🇵

Country

JAPAN
🏢

Address

480, Maki; Nishikan, Niigata, Niigata, Japan

Moderate Risk

FDA Import Risk Assessment

45.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
2/12/2018
Latest Refusal
2/12/2018
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

835×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
2/12/2018
35AHT01GELATIN, FLAVORED
83NO PROCESS
Division of West Coast Imports (DWCI)
2/12/2018
35AHT01GELATIN, FLAVORED
83NO PROCESS
Division of West Coast Imports (DWCI)
2/12/2018
35AHT01GELATIN, FLAVORED
83NO PROCESS
Division of West Coast Imports (DWCI)
2/12/2018
35AHT01GELATIN, FLAVORED
83NO PROCESS
Division of West Coast Imports (DWCI)
2/12/2018
35AHT01GELATIN, FLAVORED
83NO PROCESS
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is BOURBON CORPORATION's FDA import refusal history?

BOURBON CORPORATION (FEI: 2000006691) has 5 FDA import refusal record(s) in our database, spanning from 2/12/2018 to 2/12/2018.

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. BOURBON CORPORATION's FEI number is 2000006691.

What types of violations has BOURBON CORPORATION received?

BOURBON CORPORATION 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 BOURBON CORPORATION come from?

All FDA import refusal data for BOURBON 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.