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INAGORA, INC.

⚠️ Moderate Risk

FEI: 3019906937 • Matsudo, Chiba • JAPAN

FEI

FEI Number

3019906937

📍

Location

Matsudo, Chiba

🇯🇵

Country

JAPAN
🏢

Address

5 Chome 13-3 Akasaka Garden City 16f, Minoridai, Matsudo, Chiba, Japan

Moderate Risk

FDA Import Risk Assessment

42.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/15/2022
Latest Refusal
4/15/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
11.1×20%
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

751×

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
4/15/2022
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is INAGORA, INC.'s FDA import refusal history?

INAGORA, INC. (FEI: 3019906937) has 1 FDA import refusal record(s) in our database, spanning from 4/15/2022 to 4/15/2022.

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. INAGORA, INC.'s FEI number is 3019906937.

What types of violations has INAGORA, INC. received?

INAGORA, 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 INAGORA, INC. come from?

All FDA import refusal data for INAGORA, 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.