Societe De Fabrication De Materiel
⚠️ Moderate Risk
FEI: 3003395748 • Tunis • TUNISIA
FEI Number
3003395748
Location
Tunis
Country
TUNISIAAddress
Rte El Mahdia Km 1-6 Rueel Karama 3002, , Tunis, , Tunisia
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2002 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Florida District Office (FLA-DO) | |
| 12/27/2001 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Florida District Office (FLA-DO) | |
| 12/27/2001 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Florida District Office (FLA-DO) | |
| 12/5/2001 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Florida District Office (FLA-DO) | |
| 11/2/2001 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Florida District Office (FLA-DO) | |
| 10/18/2001 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Florida District Office (FLA-DO) | |
| 10/18/2001 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Florida District Office (FLA-DO) | |
| 10/18/2001 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Florida District Office (FLA-DO) | |
| 10/18/2001 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Florida District Office (FLA-DO) | |
| 10/18/2001 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Florida District Office (FLA-DO) | |
| 10/18/2001 | 78FJKSET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Societe De Fabrication De Materiel's FDA import refusal history?
Societe De Fabrication De Materiel (FEI: 3003395748) has 11 FDA import refusal record(s) in our database, spanning from 10/18/2001 to 1/7/2002.
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. Societe De Fabrication De Materiel's FEI number is 3003395748.
What types of violations has Societe De Fabrication De Materiel received?
Societe De Fabrication De Materiel 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 Societe De Fabrication De Materiel come from?
All FDA import refusal data for Societe De Fabrication De Materiel 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.