Aso Pharmaceutical Company, Ltd
⚠️ Moderate Risk
FEI: 1000414460 • Kikuchi-Gun, Kumamoto • JAPAN
FEI Number
1000414460
Location
Kikuchi-Gun, Kumamoto
Country
JAPANAddress
91-1, Oazatsukure; Kikuyo-Machi, Kikuchi-Gun, Kumamoto, Japan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
Refusal History
Frequently Asked Questions
What is Aso Pharmaceutical Company, Ltd's FDA import refusal history?
Aso Pharmaceutical Company, Ltd (FEI: 1000414460) has 2 FDA import refusal record(s) in our database, spanning from 4/22/2015 to 7/7/2015.
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. Aso Pharmaceutical Company, Ltd's FEI number is 1000414460.
What types of violations has Aso Pharmaceutical Company, Ltd received?
Aso Pharmaceutical Company, 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 Aso Pharmaceutical Company, Ltd come from?
All FDA import refusal data for Aso Pharmaceutical Company, 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.