Bio Mate Inter Co. Ltd
⚠️ Moderate Risk
FEI: 3007959021 • Thanyaburi, Pathum Thani • THAILAND
FEI Number
3007959021
Location
Thanyaburi, Pathum Thani
Country
THAILANDAddress
20, 3 Rangsit-Nakhon Nayok 27, Thanyaburi, Pathum Thani, Thailand
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.
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 Bio Mate Inter Co. Ltd's FDA import refusal history?
Bio Mate Inter Co. Ltd (FEI: 3007959021) has 1 FDA import refusal record(s) in our database, spanning from 1/7/2010 to 1/7/2010.
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. Bio Mate Inter Co. Ltd's FEI number is 3007959021.
What types of violations has Bio Mate Inter Co. Ltd received?
Bio Mate Inter 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 Bio Mate Inter Co. Ltd come from?
All FDA import refusal data for Bio Mate Inter 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.