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Maruzen Pharmaceuticals Co. Ltd

⚠️ Moderate Risk

FEI: 3003097457 • Onomichi, Hiroshima • JAPAN

FEI

FEI Number

3003097457

📍

Location

Onomichi, Hiroshima

🇯🇵

Country

JAPAN
🏢

Address

14703-10, Mukaihigashi-Cho, Onomichi, Hiroshima, Japan

Moderate Risk

FDA Import Risk Assessment

45.5
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
1/20/2011
Latest Refusal
2/9/2005
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
8.4×10%
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

755×

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
1/20/2011
54EYR99HERBALS & BOTANICAL TEAS, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
1/20/2011
54EYR99HERBALS & BOTANICAL TEAS, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
1/20/2011
54EYR99HERBALS & BOTANICAL TEAS, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
5/22/2006
66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/9/2005
54FDS99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Maruzen Pharmaceuticals Co. Ltd's FDA import refusal history?

Maruzen Pharmaceuticals Co. Ltd (FEI: 3003097457) has 5 FDA import refusal record(s) in our database, spanning from 2/9/2005 to 1/20/2011.

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. Maruzen Pharmaceuticals Co. Ltd's FEI number is 3003097457.

What types of violations has Maruzen Pharmaceuticals Co. Ltd received?

Maruzen Pharmaceuticals Co. Ltd 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 Maruzen Pharmaceuticals Co. Ltd come from?

All FDA import refusal data for Maruzen Pharmaceuticals Co. Ltd 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.