Galderma Sa
✅ Low Risk
FEI: 3004916671 • Lausanne Fr • FRANCE
FEI Number
3004916671
Location
Lausanne Fr
Country
FRANCEAddress
Wold Trade Center Av De, , Lausanne Fr, , 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Galderma Sa's FDA import refusal history?
Galderma Sa (FEI: 3004916671) has 2 FDA import refusal record(s) in our database, spanning from 1/3/2005 to 1/3/2005.
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. Galderma Sa's FEI number is 3004916671.
What types of violations has Galderma Sa received?
Galderma Sa has been cited for 2 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 Galderma Sa come from?
All FDA import refusal data for Galderma 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.