SANWA KANZUME Co., Ltd. TENDO Factory
⚠️ Moderate Risk
FEI: 3004302883 • Tendo, Yamagata • JAPAN
FEI Number
3004302883
Location
Tendo, Yamagata
Country
JAPANAddress
Ngendou 455-Go, Oazashoge, Tendo, Yamagata, 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/6/2019 | 54YCY08COENZYME Q10 (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 83NO PROCESS | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is SANWA KANZUME Co., Ltd. TENDO Factory's FDA import refusal history?
SANWA KANZUME Co., Ltd. TENDO Factory (FEI: 3004302883) has 1 FDA import refusal record(s) in our database, spanning from 5/6/2019 to 5/6/2019.
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. SANWA KANZUME Co., Ltd. TENDO Factory's FEI number is 3004302883.
What types of violations has SANWA KANZUME Co., Ltd. TENDO Factory received?
SANWA KANZUME Co., Ltd. TENDO Factory 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 SANWA KANZUME Co., Ltd. TENDO Factory come from?
All FDA import refusal data for SANWA KANZUME Co., Ltd. TENDO Factory 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.