Fujika Co., Ltd.
⚠️ Moderate Risk
FEI: 3003755376 • Chiyoda, Tokyo • JAPAN
FEI Number
3003755376
Location
Chiyoda, Tokyo
Country
JAPANAddress
16, Kandamatsunaga-Cho, Chiyoda, Tokyo, 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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
Frequently Asked Questions
What is Fujika Co., Ltd.'s FDA import refusal history?
Fujika Co., Ltd. (FEI: 3003755376) has 1 FDA import refusal record(s) in our database, spanning from 2/6/2006 to 2/6/2006.
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. Fujika Co., Ltd.'s FEI number is 3003755376.
What types of violations has Fujika Co., Ltd. received?
Fujika 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 Fujika Co., Ltd. come from?
All FDA import refusal data for Fujika 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.