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Carex Inc

⚠️ Moderate Risk

FEI: 3003899586 • Osaka, Osaka • JAPAN

FEI

FEI Number

3003899586

📍

Location

Osaka, Osaka

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 1-47 Chuo, Joto; Chuo; Joto, Osaka, Osaka, Japan

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/18/2003
Latest Refusal
3/18/2003
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

2381×

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.

Refusal History

DateProductViolationsDivision
3/18/2003
46YY99FOOD ADDITIVES FOR HUMAN USE, N.E.C.
238UNSAFE ADD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Carex Inc's FDA import refusal history?

Carex Inc (FEI: 3003899586) has 1 FDA import refusal record(s) in our database, spanning from 3/18/2003 to 3/18/2003.

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. Carex Inc's FEI number is 3003899586.

What types of violations has Carex Inc received?

Carex 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 Carex Inc come from?

All FDA import refusal data for Carex 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.