Fibro Pharmaceutical Co Ltd
⚠️ Moderate Risk
FEI: 3004100740 • Adachi, Tokyo • JAPAN
FEI Number
3004100740
Location
Adachi, Tokyo
Country
JAPANAddress
3 Chome 10-6, Yazaike, Adachi, 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
PESTICIDE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or 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
Frequently Asked Questions
What is Fibro Pharmaceutical Co Ltd's FDA import refusal history?
Fibro Pharmaceutical Co Ltd (FEI: 3004100740) has 2 FDA import refusal record(s) in our database, spanning from 8/28/2003 to 11/6/2017.
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. Fibro Pharmaceutical Co Ltd's FEI number is 3004100740.
What types of violations has Fibro Pharmaceutical Co Ltd received?
Fibro Pharmaceutical 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 Fibro Pharmaceutical Co Ltd come from?
All FDA import refusal data for Fibro Pharmaceutical 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.