Japan Bio Products Co.,Ltd
⚠️ Moderate Risk
FEI: 3006894444 • Shibuya, Tokyo • JAPAN
FEI Number
3006894444
Location
Shibuya, Tokyo
Country
JAPANAddress
1 Chome 44-4, Tomigaya, Shibuya, 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
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/14/2008 | 54ACH01VITAMIN A | Los Angeles District Office (LOS-DO) | |
| 10/21/2002 | 54YYZ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | Cincinnati District Office (CIN-DO) |
| 4/6/2002 | 54GBE99ANIMAL BY-PRODUCTS AND EXTRACTS, N.E.C. | 260FALSE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Japan Bio Products Co.,Ltd's FDA import refusal history?
Japan Bio Products Co.,Ltd (FEI: 3006894444) has 3 FDA import refusal record(s) in our database, spanning from 4/6/2002 to 8/14/2008.
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. Japan Bio Products Co.,Ltd's FEI number is 3006894444.
What types of violations has Japan Bio Products Co.,Ltd received?
Japan Bio Products 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 Japan Bio Products Co.,Ltd come from?
All FDA import refusal data for Japan Bio Products 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.