Qualicaps, Co. LTD
⚠️ Moderate Risk
FEI: 3005085403 • Yamatokoriyama • JAPAN
FEI Number
3005085403
Location
Yamatokoriyama
Country
JAPANAddress
321-5, Ikezawa-Cho, Yamatokoriyama, , 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
Refusal History
Frequently Asked Questions
What is Qualicaps, Co. LTD's FDA import refusal history?
Qualicaps, Co. LTD (FEI: 3005085403) has 2 FDA import refusal record(s) in our database, spanning from 2/27/2002 to 7/11/2002.
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. Qualicaps, Co. LTD's FEI number is 3005085403.
What types of violations has Qualicaps, Co. LTD received?
Qualicaps, 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 Qualicaps, Co. LTD come from?
All FDA import refusal data for Qualicaps, 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.