Saint Ismier
⚠️ Moderate Risk
FEI: 3006395536 • Cedex • FRANCE
FEI Number
3006395536
Location
Cedex
Country
FRANCEAddress
655 Ave De L Europe Montbonnot, , Cedex, , 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).
Refusal History
Frequently Asked Questions
What is Saint Ismier's FDA import refusal history?
Saint Ismier (FEI: 3006395536) has 2 FDA import refusal record(s) in our database, spanning from 8/15/2007 to 8/15/2007.
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. Saint Ismier's FEI number is 3006395536.
What types of violations has Saint Ismier received?
Saint Ismier 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 Saint Ismier come from?
All FDA import refusal data for Saint Ismier 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.