ACTALYS
✅ Low Risk
FEI: 3016919725 • Homecourt, Meurthe Et Moselle • FRANCE
FEI Number
3016919725
Location
Homecourt, Meurthe Et Moselle
Country
FRANCEAddress
Zone Industrielle De Haut De Tappes, Rue De La Mine, Homecourt, Meurthe Et Moselle, 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
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 |
|---|---|---|---|
| 8/11/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is ACTALYS's FDA import refusal history?
ACTALYS (FEI: 3016919725) has 1 FDA import refusal record(s) in our database, spanning from 8/11/2020 to 8/11/2020.
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. ACTALYS's FEI number is 3016919725.
What types of violations has ACTALYS received?
ACTALYS 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 ACTALYS come from?
All FDA import refusal data for ACTALYS 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.