Sophysa
⚠️ Moderate Risk
FEI: 3001587388 • Besancon, Doubs • FRANCE
FEI Number
3001587388
Location
Besancon, Doubs
Country
FRANCEAddress
Rue Sophie Germain, , Besancon, Doubs, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/10/2016 | 84JXGSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/10/2016 | 84JXGSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/10/2016 | 84JXGSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/10/2016 | 84JXGSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/10/2016 | 84JXGSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Sophysa's FDA import refusal history?
Sophysa (FEI: 3001587388) has 5 FDA import refusal record(s) in our database, spanning from 6/10/2016 to 6/10/2016.
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. Sophysa's FEI number is 3001587388.
What types of violations has Sophysa received?
Sophysa 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 Sophysa come from?
All FDA import refusal data for Sophysa 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.