Arex SARL
⚠️ Moderate Risk
FEI: 3003467879 • Palaiseau, Essonne • FRANCE
FEI Number
3003467879
Location
Palaiseau, Essonne
Country
FRANCEAddress
3 Allee Du Clos Tonnerre, , Palaiseau, Essonne, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/7/2014 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) | |
| 10/7/2014 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) | |
| 10/7/2014 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Arex SARL's FDA import refusal history?
Arex SARL (FEI: 3003467879) has 3 FDA import refusal record(s) in our database, spanning from 10/7/2014 to 10/7/2014.
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. Arex SARL's FEI number is 3003467879.
What types of violations has Arex SARL received?
Arex SARL 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 Arex SARL come from?
All FDA import refusal data for Arex SARL 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.