Nihon Vitamin Chemical Co Ltd
⚠️ Moderate Risk
FEI: 3002701756 • Toyama • 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
PESTICIDE2
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/6/2012 | 54FYY99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3721PESTICIDE2 | New Orleans District Office (NOL-DO) |
| 2/23/2009 | 54FDH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2920PESTICIDES | Southwest Import District Office (SWI-DO) |
| 8/6/2008 | 41YCY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/6/2008 | 41YCY99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Nihon Vitamin Chemical Co Ltd's FDA import refusal history?
Nihon Vitamin Chemical Co Ltd (FEI: 3002701756) has 4 FDA import refusal record(s) in our database, spanning from 8/6/2008 to 7/6/2012.
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. Nihon Vitamin Chemical Co Ltd's FEI number is 3002701756.
What types of violations has Nihon Vitamin Chemical Co Ltd received?
Nihon Vitamin Chemical Co Ltd has been cited for 3 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 Nihon Vitamin Chemical Co Ltd come from?
All FDA import refusal data for Nihon Vitamin Chemical 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.