Biomatalante
⚠️ Moderate Risk
FEI: 3002420773 • Vigneux-De-Bretagne, Loire-Atlantique • FRANCE
FEI Number
3002420773
Location
Vigneux-De-Bretagne, Loire-Atlantique
Country
FRANCEAddress
5 Rue Edouard Belin, , Vigneux-De-Bretagne, Loire-Atlantique, France
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
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Biomatalante's FDA import refusal history?
Biomatalante (FEI: 3002420773) has 2 FDA import refusal record(s) in our database, spanning from 12/23/2002 to 2/26/2008.
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. Biomatalante's FEI number is 3002420773.
What types of violations has Biomatalante received?
Biomatalante 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 Biomatalante come from?
All FDA import refusal data for Biomatalante 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.