ANTHOGYR SAS
✅ Low Risk
FEI: 4224 • Sallanches, Haute-savoie • FRANCE
FEI Number
4224
Location
Sallanches, Haute-savoie
Country
FRANCEAddress
2237 Avenue Andre Lasquin, , Sallanches, Haute-savoie, France
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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 |
|---|---|---|---|
| 3/24/2014 | 87HXCWRENCH | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is ANTHOGYR SAS's FDA import refusal history?
ANTHOGYR SAS (FEI: 4224) has 1 FDA import refusal record(s) in our database, spanning from 3/24/2014 to 3/24/2014.
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. ANTHOGYR SAS's FEI number is 4224.
What types of violations has ANTHOGYR SAS received?
ANTHOGYR SAS 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 ANTHOGYR SAS come from?
All FDA import refusal data for ANTHOGYR SAS 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.