VYGON S A
⚠️ Moderate Risk
FEI: 3009291251 • Ecouen Ile-De-France, Val d'Oise • FRANCE
FEI Number
3009291251
Location
Ecouen Ile-De-France, Val d'Oise
Country
FRANCEAddress
5 Rue Adeline, 5-11 RUE ADELINE, Ecouen Ile-De-France, Val d'Oise, 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
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.
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 |
|---|---|---|---|
| 10/29/2013 | 77LRCINSTRUMENT, ENT MANUAL SURGICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 6/1/2010 | 80FOSCATHETER, UMBILICAL ARTERY | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/1/2010 | 80FOSCATHETER, UMBILICAL ARTERY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/1/2010 | 73BYEATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/1/2010 | 80FOSCATHETER, UMBILICAL ARTERY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/1/2010 | 80FOSCATHETER, UMBILICAL ARTERY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/1/2010 | 80FOSCATHETER, UMBILICAL ARTERY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/1/2010 | 80FOSCATHETER, UMBILICAL ARTERY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/1/2010 | 80FOSCATHETER, UMBILICAL ARTERY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/28/2009 | 80FOSCATHETER, UMBILICAL ARTERY | Division of Southeast Imports (DSEI) | |
| 5/28/2009 | 80FOSCATHETER, UMBILICAL ARTERY | Division of Southeast Imports (DSEI) | |
| 5/28/2009 | 73BYEATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE | Division of Southeast Imports (DSEI) | |
| 3/3/2009 | 73BYEATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/3/2009 | 80FOSCATHETER, UMBILICAL ARTERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/3/2009 | 80FOSCATHETER, UMBILICAL ARTERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/6/2008 | 80FOSCATHETER, UMBILICAL ARTERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/6/2008 | 80FOSCATHETER, UMBILICAL ARTERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/11/2008 | 79KGZACCESSORIES, CATHETER | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/11/2008 | 80FOSCATHETER, UMBILICAL ARTERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/11/2008 | 80FOSCATHETER, UMBILICAL ARTERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/11/2008 | 84HASNEEDLE, NEUROSURGICAL SUTURE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/11/2008 | 73BYEATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/11/2008 | 80FOSCATHETER, UMBILICAL ARTERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/11/2008 | 84NHINERVE, STIMULATOR, ELECTRICAL, PERCUTANEOUS (PENS) FOR PAIN RELIEF | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/11/2008 | 80MWVNEEDLES, MEDICAMENT DISPENSING TIP & IRRIGATING | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/11/2008 | 73BYEATTACHMENT, BREATHING, POSITIVE END EXPIRATORY PRESSURE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/11/2008 | 80FOSCATHETER, UMBILICAL ARTERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/11/2008 | 80FOSCATHETER, UMBILICAL ARTERY | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/12/2004 | 79JCYCATHETER, INFUSION | Florida District Office (FLA-DO) | |
| 5/12/2004 | 80LJSCATHETER, PERCUTANEOUS, INTRAVASCULAR, LONG TERM | Florida District Office (FLA-DO) | |
| 5/12/2004 | 80BYYTUBE, ASPIRATING, FLEXIBLE, CONNECTING | Florida District Office (FLA-DO) | |
| 5/12/2004 | 80FOSCATHETER, UMBILICAL ARTERY | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is VYGON S A's FDA import refusal history?
VYGON S A (FEI: 3009291251) has 32 FDA import refusal record(s) in our database, spanning from 5/12/2004 to 10/29/2013.
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. VYGON S A's FEI number is 3009291251.
What types of violations has VYGON S A received?
VYGON S A 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 VYGON S A come from?
All FDA import refusal data for VYGON S A 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.