Biosafe Sa
✅ Low Risk
FEI: 3004728017 • Eysins • SWITZERLAND
FEI Number
3004728017
Location
Eysins
Country
SWITZERLANDAddress
Rte Du Petit-Eysins, , Eysins, , Switzerland
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 |
|---|---|---|---|
| 12/23/2013 | 81OAOCORD BLOOD PROCESSING SYSTEM AND STORAGE CONTAINER | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Biosafe Sa's FDA import refusal history?
Biosafe Sa (FEI: 3004728017) has 1 FDA import refusal record(s) in our database, spanning from 12/23/2013 to 12/23/2013.
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. Biosafe Sa's FEI number is 3004728017.
What types of violations has Biosafe Sa received?
Biosafe Sa 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 Biosafe Sa come from?
All FDA import refusal data for Biosafe Sa 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.