Tous Les Biomateriaux
⚠️ Moderate Risk
FEI: 3008794636 • Nice, Alpes Maritimes • FRANCE
FEI Number
3008794636
Location
Nice, Alpes Maritimes
Country
FRANCEAddress
49 Rue Gioffredo, , Nice, Alpes Maritimes, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/24/2011 | 79GAXTOURNIQUET, NONPNEUMATIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 81GIOTUBE, COLLECTION, CAPILLARY BLOOD | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Tous Les Biomateriaux's FDA import refusal history?
Tous Les Biomateriaux (FEI: 3008794636) has 3 FDA import refusal record(s) in our database, spanning from 8/24/2011 to 8/24/2011.
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. Tous Les Biomateriaux's FEI number is 3008794636.
What types of violations has Tous Les Biomateriaux received?
Tous Les Biomateriaux has been cited for 1 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 Tous Les Biomateriaux come from?
All FDA import refusal data for Tous Les Biomateriaux 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.