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Honso Pharmaceuticals Co., Ltd

⚠️ Moderate Risk

FEI: 3003873450 • Nagoya, Aichi • JAPAN

FEI

FEI Number

3003873450

📍

Location

Nagoya, Aichi

🇯🇵

Country

JAPAN
🏢

Address

3 Chome 6-21, Marunochi; Naka, Nagoya, Aichi, Japan

Moderate Risk

FDA Import Risk Assessment

45.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
5/11/2004
Latest Refusal
5/11/2004
Earliest Refusal

Score Breakdown

Violation Severity
95.0×40%
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

2511×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

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
5/11/2004
54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
5/11/2004
54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
251POISONOUS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

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

Honso Pharmaceuticals Co., Ltd (FEI: 3003873450) has 2 FDA import refusal record(s) in our database, spanning from 5/11/2004 to 5/11/2004.

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. Honso Pharmaceuticals Co., Ltd's FEI number is 3003873450.

What types of violations has Honso Pharmaceuticals Co., Ltd received?

Honso Pharmaceuticals Co., Ltd has been cited for 2 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 Honso Pharmaceuticals Co., Ltd come from?

All FDA import refusal data for Honso 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.