Tomofuji Shoji Co., Ltd.
⚠️ Moderate Risk
FEI: 1000255977 • Kobe, Hyogo • JAPAN
FEI Number
1000255977
Location
Kobe, Hyogo
Country
JAPANAddress
1 Chome 4-5, Yasakadai; Suma, Kobe, Hyogo, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
Frequently Asked Questions
What is Tomofuji Shoji Co., Ltd.'s FDA import refusal history?
Tomofuji Shoji Co., Ltd. (FEI: 1000255977) has 2 FDA import refusal record(s) in our database, spanning from 5/16/2002 to 7/2/2003.
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. Tomofuji Shoji Co., Ltd.'s FEI number is 1000255977.
What types of violations has Tomofuji Shoji Co., Ltd. received?
Tomofuji Shoji 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 Tomofuji Shoji Co., Ltd. come from?
All FDA import refusal data for Tomofuji Shoji 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.